Method of treating urinary incontinence

ABSTRACT

A method of treating urinary incontinence in a patient includes forming one and only one incision in the patient and implanting a base of a support by placing an anchor into tissue of an obturator foramen. The anchor is attached to the base of the support by a continuous suture loop that is looped through an eyelet of the anchor and engaged through the base of the support. The method includes breaking the continuous suture loop, tying a knot in the suture, and fixating the base of the support in the patient. An arm of the support is implanted by placing a second anchor into periosteum tissue lateral to a pubic symphysis with a second continuous suture loop looped through an eyelet of the second anchor and engaged through the arm of the support.

BACKGROUND

Some surgical implants are fixed in place with one or more suture knots.Other surgical implants, for example fabric or mesh supports, are fixedin place with an anchor attached to a suture, where the suture is tiedagainst the support. These surgical implants are usefully employed totreat male or female incontinence, pelvic organ prolapse, and inreconstructing areas of tissue.

Improved devices and methods of fixating surgical implants would bewelcomed by patients and healthcare workers.

SUMMARY

One aspect provides a tissue anchor system including a support material,a suture engaged with the support material, an anchor assembly, and anintroducer. The anchor assembly includes an insertion tab removablysecured to an anchor. The anchor includes a body having a mid-pointlocated between a leading end and a trailing end, with a tissueengagement fin forming an upper edge of the body, and an eyelet formedin the tissue engagement pod. The tissue engagement fin is asymmetricrelative to the mid-point. The introducer has a cannula defining a slotsized to receive the body of the anchor and an ejection mechanismprovided to eject the anchor out of the cannula.

One aspect provides a tissue anchor having a body, protrusions from thebody, and a tissue engaging fin. The body is oriented on a longitudinalaxis and has a leading tip, a leading end portion extending from theleading tip, a trailing end portion connected to the leading endportion, with the trailing end portion terminating in a trailing tipthat is located opposite of the leading tip. First and secondprotrusions are formed on the leading end portion of the body, with eachof the first and second protrusions extending outward in a radialdirection perpendicular to the longitudinal axis. A first anchor widthmeasured between the first and second protrusions is greater than asecond anchor width measured at the trailing end portion of the body.The tissue engaging fin is integrated with the leading end portion ofthe body and oriented in a direction perpendicular to the radialdirection of the first and second protrusions. The tissue engaging finhas a fin width and is provided with an eyelet formed through the finwidth. A gripping tab is removably attached to the tissue engaging fin.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other.

FIG. 1 is a top view of one embodiment of a tissue anchor systemincluding a support material, and anchor assembly, and an introducer.

FIG. 2 is a top view of one embodiment of the support materialillustrated in FIG. 1.

FIG. 3 is a top schematic view of the support material illustrated inFIG. 2 superimposed over a different support material.

FIG. 4 is a perspective view of one embodiment of the introducerillustrated in FIG. 1.

FIG. 5 is a perspective view of the introducer illustrated in FIG. 4.

FIG. 6 is a perspective view of an end portion of a cannula of theintroducer illustrated in FIG. 4.

FIG. 7 is a top view, FIG. 8 is a side view, and FIG. 9 is across-sectional view of the cannula of the introducer illustrated inFIG. 4.

FIG. 10A is a perspective view and FIG. 10B is a side view of oneembodiment of the anchor assembly illustrated in FIG. 1.

FIG. 11 is a perspective view of one embodiment of the anchor assemblyillustrated in FIG. 1.

FIG. 12 is a side view of one embodiment of the anchor assemblyillustrated in FIG. 1.

FIG. 13 is a top view of one embodiment and FIG. 14 is a side view ofone embodiment of anchor assemblies suitable for use with the tissueanchor system illustrated in FIG. 1.

FIG. 15 is a perspective view of one embodiment of an anchor suitablefor use with the tissue anchor system illustrated in FIG. 1.

FIG. 16 is a top view and FIG. 17 is a bottom view of the anchorillustrated in FIG. 15.

FIG. 18A is cross-sectional view of the leading end portion of theanchor and FIG. 18B is cross-sectional view of the trailing end portionof the anchor.

FIGS. 19-20 are perspective views of the anchor illustrated in FIG. 15ejected into soft tissue from the cannula illustrated in FIG. 6.

FIGS. 21A-21C are schematic views of the anchor illustrated in FIG. 15rotated into engagement with tissue.

FIGS. 22A-22K are schematic views of embodiments of a process forimplanting the tissue anchor system illustrated in FIG. 1 in a person totreat urinary incontinence.

FIG. 23 is a perspective view of one embodiment of an anchor assemblycoupled to an introducer and suitable for use in the tissue anchorsystem illustrated in FIG. 1.

FIG. 24 is a side view of an anchor assembly attachable to a pinextending from an introducer.

FIG. 25 is a side view of the anchor assembly attached to the pinillustrated in FIG. 24.

FIGS. 26-38 are illustrations of embodiments of anchors suitable for usein the tissue anchor system.

FIGS. 39-46 are views of embodiments of anchors suitable for use in thetissue anchor system.

FIG. 47 is a perspective view of one embodiment of an anchor assembly.

FIG. 48 is a perspective view of one embodiment of an anchor assemblyincluding a stop knot engagement feature.

FIG. 49 is a perspective view of one embodiment of a surgical systemincluding anchors insertable into a dual cannula introducer.

FIG. 50 is a schematic view of one embodiment of the surgical systemprovided to anchor a support material to tissue of the human body, withthe support material having an arm inserted through each of twoobturator foramen of the pelvis.

FIG. 51 is a schematic view of one embodiment of the surgical systememployed to anchor a support material to the tissue of the human bodyshowing a pre-pubic portion being attached to the periosteum of thepubic bone.

FIG. 52 is a schematic view of the anchor secured to tissue andincluding a stopper coupled with a suture and located between the anchorand a slip knot.

FIG. 53 is a schematic view of two anchors secured to tissue and coupledwith a suture.

FIGS. 54-62 are schematic views of embodiments of a method of anchoringa support material to tissue.

FIGS. 63-68B are schematic views of embodiments of a method of anchoringa support material to tissue.

FIGS. 69-73 are schematic views of embodiments of a method of anchoringa support material to tissue.

FIG. 74 is a schematic view illustrating embodiments of methods ofanchoring a support to the pelvis of a male patient.

FIG. 75 is a perspective view of one embodiment of an adjustableincontinence treatment device.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

The features of the various exemplary embodiments described in thisapplication are suitable and intended to be combined with each other,unless specifically noted otherwise.

Anterior means “forward” or “front,” and posterior means “rearward” or“back.” Relative to surfaces of an organ in the human body, an anteriorsurface of an instrument inserted into the organ will be orientedforward toward the belly and a posterior surface will be orientedrearward toward the spine.

End means an end-most location and end portion means that segmentadjacent to and near the end of an object. For example, two opposingends of an object are each equidistant from a mid-point of the objectand between the mid-point and each end of the object is an end portionof the object.

Soft tissue is tissue other than bone. Soft tissue is not bone.

Embodiments provide a tissue anchor having a geometric asymmetry andasymmetric mass distribution along a length of the anchor whichencourages the anchor to be rotated into a stable configuration in thetissue.

Embodiments provide a tissue anchor system having an anchor that willdurably anchor into periosteum tissue covering a bony surface, ordurably anchor into dense fibrous tissue where muscle inserts into thebone. An anchor so anchored is suitable for suspending support materialor is useful in implanting devices in the human body.

Embodiments provide a tissue anchor system including an introducer thatis configured to deliver an anchor to an intracorporeal tissue site. Theintroducer includes a cannula that allows placement of an anchor at alandmark in tissue deep within an incision site, which may be out of thefield of vision of the surgeon. The anchor is configured to be securedwithin the cannula so that it does not rotate or fall out of the cannuladuring insertion into the tissue. A length of suture is provided that isattached to the anchor, where the suture may be tied or otherwiseterminated to itself outside of the incision site and then subsequentlydirected to the intracorporeal landmark.

Embodiments provide a tissue anchor system provided to treat maleurinary incontinence that is advantageously implanted through a singleincision formed in the patient. A first anchor is anchored to the tissueof a first obturator foramen of the patient, and a second anchor isanchored to the tissue of a second obturator foramen of the patient tosecure in inferior portion of the support material to the patient. Athird anchor is provided to anchor a first pre-pubic arm to theperiosteum tissue on one side of the pubic symphysis, and a fourthanchor is provided to anchor a second pre-pubic arm of the supportmaterial to the periosteum tissue on the other side of the pubicsymphysis. Each of the anchor assemblies includes a suture extendingfrom an anchor, and the surgeon is instructed to suitably terminate ortighten the suture to capture the support material between a knot formedin the suture and the anchor implanted in the tissue. The surgeon,guided by experience and instruction provided with the tissue anchorsystem, follows a routine of first centering and fixating the inferiorportion of the support material relative to the obturator foramen bysuitably tensioning and tying knots in the suture. Subsequently, thesurgeon centers and fixates the superior portion of the support materialnear an upper portion of the pelvis on either side of the pubicsymphysis. Some aspects of the tissue anchoring system include aseparate plication mechanism provided to take up the slack in tensionthe support material over the tissue of the urethra.

Some incontinence treatment devices have several arms, including someform of arms that traverse the obturator foramen (called transobturatorarms) and other arms that are implanted anterior to the pubic bone(called pre-pubic arms). A first set of tools is used to place thetransobturator arms and a second, different set of tools is used toplace the pre-pubic arms. The pre-pubic arms are inserted into a firstincision and tunnelled anterior to the pelvis to exit the skin of theabdomen through a second incision and respective third incision.

In contrast, embodiments of the system described in this specificationprovide a support material that is implantable into the patient througha single incision with anchor assemblies that do not create a second orother incisions/openings in the skin. The system obviates the use oftransobturator arms and additional tools that tunnel the pre-pubic armsunder the skin. The system is easier to implant compared to a four armor six arm support, and reduces the amount of time that the patient isin the operating room.

One approach to treating urinary incontinence places a support inferiorto the urethra and directs arms upward from the support alongside thebladder along a U-shaped pathway. A significant advance over theU-shaped pathway was provided by Dr. Emmanuel Delorme as described inhis U.S. Pat. No. 6,638,211 and included placing arms of a supportthrough the obturator foramen along a V-shaped pathway. This applicationprovides another advance in supporting the pelvic anatomy by recognizingthat support material can be robustly attached to the periosteum tissuethrough the use of an anchoring system. The anchoring system allows thesurgeon to place the support inside of the patient and directly fixatethe support to periosteum tissue that is present over the exterior ofthe pelvis bone. This approach does away with needles and other toolsthat tunnel the arms of a support through tissue. The anchoring systemdescribed in this application is compatible with a true single (onlyone) incision formed in the patient.

FIG. 1 is a top view of one embodiment of a tissue anchor system 20 (thesystem 20). The system 20 is illustrated in one useful form for deliveryto an end-user healthcare facility and includes a support material 22,sutures 24 engaged with the support material 22, an anchor assembly 26engaged with each of the sutures 24, and a set of introducers 28.

The support material 22 is provided to support the urethra whenimplanted in the patient. Suitable materials for the support material 22include autograft material (the patient's own tissue), allograftmaterial (tissue from a cadaver), xenograft material (tissue fromanother species), or synthetic materials such as woven fabrics, knittedfabrics, meshes, nonwoven fabrics, meshes, fibrillated fibers, or spunand fibrillated fibers. In some embodiments, the support material 22 isfabricated to include voids (pores) configured to allow tissue ingrowthinto the support material 22. The pores are generally larger, onaverage, than 75 μm. One suitable support material 22 is a knittedpolypropylene mesh, where each strand of the mesh is knitted from apolypropylene filament.

The sutures 24 are threaded through or otherwise engaged with thesupport material 22. Each suture 24 is threaded through or otherwiseengaged with one anchor assembly 26. One suitable suture 24 isfabricated from a single monofilament of polypropylene that is threadedthrough both the anchor assembly 26 and the support material 22 to forma continuous closed loop of suture. In one embodiment, the trailing endportions of each suture 24 are brought together and maintained within aconduit 29, and at least the ends of the suture 24 are welded (heatwelded or sonically welded) together to maintain the ends of thecontinuous closed loop of suture in an organized fashion until thesurgeon desires to break the suture 24 at the point of the weld. In oneembodiment, the weld is a break pad 30 that is formed by crushing theends of the suture 24 into a flat structure that is more brittle thanand easier to break than the suture 24 is itself. The break pad 30maintains the suture 24 in an organized fashion until the surgeondesires to access the free ends of the suture 24 and tie a knot. In oneembodiment, the welded break pad 30 is formed through the ends of thesuture 24 and through the conduit 29. The conduit 29 advantageouslyallows the surgeon to identify which suture strand is associated witheach portion of the support 22 and also manages the sutures into anorganized bundle for ease of handling during implantation of the support22.

The anchor assembly 26 includes an insertion tab 40 that is removablysecured to an anchor 42. The anchor 42 includes a body 44, a tissueengagement fin 46 attached to the body 44, and an eyelet 48 formed inthe tissue engagement fin 46. The suture 24 is threaded through theeyelet 48 and gathered/secured at the break pad 30. The insertion tab 40provides a convenient handle for the surgeon or the surgical staff tohandle the anchor 42. The length of the anchor 42 is in a range fromabout 4-20 mm, which can present a small area for grasping when a personis wearing surgical gloves. The insertion tab 40 allows the surgeon orthe surgical staff to handle the anchor 42 comfortably when loading theanchor 42 into the introducer 28.

The set of introducers 28 includes a first tool 28 a for passing oneanchor 26 to the patient's right side obturator membrane and a secondtool 28 b for passing a second anchor 26 to the patient's left sideobturator membrane. Each of the introducers 28 a, 28 b includes acannula 50 extending from a handle 52, and an ejection mechanism 54including a button 56 that communicates with a rod/wire disposed withinthe cannula 50. Movement of the button 56 in a distal direction(forward) moves the rod/wire in a distal direction, which acts upon theanchor 42 to eject the anchor out of the cannula 50. The introducers 28a, 28 b have a “handedness” depending on whether the anchor 42 is into aleft or a right obturator foramen. However, each introducer 28 a or 28 bis equally well suited for inserting one of the anchors 42 intoperiosteum tissue.

An optional a plication mechanism 70 is engaged with the supportmaterial 22. The plication mechanism 70 operates to gather up any slackthat might be present in the support 22 after implantation.

FIG. 2 is a top view of four anchor assemblies 42 a, 42 b, 42 c, 42 dincluding an insertion tab 40 and engaged with the support material 22.The anchors 42 are located between the support 22 and the patient'sbody, and the conduits 29 and the break pads 30 are located between thesupport 22 and the surgeon. Thus, relative to the support 22, theanchors 42 are located posterior (distal the surgeon) and the conduits29/break pads 30 are located anterior (proximal the surgeon).

Each of the four anchor assemblies 42 a, 42 b, 42 c, 42 d is engagedwith the support material 22 by a respective suture 24 a, 24 b, 24 c, 24d, where each suture 24 a, 24 b, 24 c, 24 d penetrates the support 22 atmore than one location. In the embodiment illustrated, each suture 24 a,24 b, 24 c, 24 d penetrates the support 22 at two locations. We studiedthe effectiveness of the compression provided by the support 22 inelevating and compressing the urethra and have determined that themultiplicity of penetrations of the support 22 by the suture 24 asillustrated in FIG. 2 provides optimal support to the urethra. Forexample, two penetration points for the sutures 24 a, 24 b on each sideof the base 60 (four penetrations total for two sutures 24 a, 24 b)provides excellent suspension of the base 60 between the obturatorforamen when the support 22 is implanted. Two penetration pointsoriented on a diagonal line from an interior location of an arm 62, 64to an outside corner of each arm 62, 64 for each suture 24 c, 24 d hasbeen determined to provide excellent tension to the support 22 whenimplanted.

The support material 22 includes a base 60 associated with a firstanchor 42 a that is provided to be anchored into a first obturatormembrane and a second anchor 42 b that is provided to be anchored into asecond obturator membrane of the patient. The support material 22additionally includes a first pre-pubic arms 62 associated with a thirdanchor 42 c that is provided to be anchored into the periosteum tissueon one side of the pubic symphysis, and a second pre-pubic arms 64associated with a fourth anchor 42 d that is provided to be anchoredinto the periosteum tissue on the other side of the pubic symphysis. Thesupport material 22 is provided to hospital or the surgeon in a packagewith instructions for use and includes each of the four anchors 42 a-42d engaged with the support material 22 by one of the respective sutures24 a-24 d.

In one embodiment, a plication mechanism 70 is engaged with the supportmaterial 22. The plication mechanism 70 is provided to allow the surgeonto remove slack from a central region of the support material 22 afterthe base 60 and the pre-pubic arms 62, 64 have been secured to tissue.In one embodiment, the plication mechanism 70 is a single strand ofpolypropylene suture that is looped into a three-circle configuration (asnowman configuration). When force is applied to the free ends 72, 74 ofthe plication mechanism 70, each of the circles in the three-circleconfiguration is contracted to remove the slack from the central portionof the support material 22. The ends 72, 74 for plication mechanism canbe welded into a break pad, or are tied into a suitable knot to tensionthe support material 22 against the tissue of the urethra. The plicationmechanism 70 may be removed from the support 22 by the surgeon afterimplantation if it is determined that the support material 22 is lyingas desired over the tissue. In one embodiment, the plication mechanism70 includes a conduit 71 provided to manage the loose ends of theplication suture.

Single Incision Male Sling—SIMS

One approach to attaching a support 22 in treating male urinaryincontinence is made with reference to FIGS. 1 and 2. The patient isplaced in gentle lithotomy position with buttock at the edge of thetable. Insert a 14 French Foley catheter. A single (one and only one)incision (about 4-6 cm) is made vertically in the perineal tissue 1 cmanterior to the anus. The surgeon is instructed to dissect down to andisolate the ventral bulbous urethra keeping the bulbospongiosus muscleintact. The surgeon is instructed to expose the bulbospongiosus muscleand take down the central tendon 2 cm to provide urethral mobility andallow for sling re-approximation. The surgeon is instructed to dissectsufficiently to accommodate the entire support 22 and for incorporationof a wound retractor.

The system 20 is appropriate both for use in procedures where thesurgeon dissects the bulbous spongiosis muscle and in procedures wherethe surgeon does not dissect the bulbous spongiosis muscle, as dependsupon surgeon preference.

One of the anchors 42 is loaded into a bore of one of the introducers 28a, 28 b by following the arrow provided on the tab 40. The tab 40 isremoved and discarded after the anchor 42 is inserted into the bore ofthe introducer 28. The anchors 42 are placed in the obturator foramenfollowing a trans-obturator (TO) path that is referred to as a TOapproach. The introducer 28 is directed through the incision using aninside-out technique to guide the anchor 42 through the membrane overone of the left or right obturator foramen. Start the introducer 28passage about 2 finger breadths (approximately 4 cm) below the pubicarch. The shaft of the introducer 28 should be parallel with theipsilateral ischial pubic ramus. Using the thumb, push the introducer 28posterior past the ischial pubic ramus, advancing through the obturatormembrane until a pop is felt. Once the “pop” is felt, rotate anadditional ¼ turn (thumb slide should be facing up). The introducer 28and the anchor 42 in the introducer 28 may be repositioned as desired bythe surgeon until the anchor 42 is physically expelled from theintroducer 28. The surgeon is instructed to deploy anchor using thumbadvance 56. The anchor 42 is inserted into the obturator externusmuscle. The surgeon is instructed to withdraw the introducer 28, pull onthe suture 24 to seat the anchor 42 in the tissue, and ensure integrityof the anchoring.

In a similar manner on the contralateral side, a second of the anchors42 is loaded into the introducer 28, and introducer 28 is directedthrough the incision to guide the anchor 42 through the membrane overthe other left or right obturator foramen for insertion into thatobturator externus muscle.

The surgeon is instructed to center the support 22 on thebulbospongiosus muscle, using a stay suture if desired. The surgeon isinstructed to retract the catheter from the glans penis. The surgeon isinstructed to remove the conduit 29 from the suture 24 and to separatesuture ends by pulling apart the break pad 30. The surgeon is instructedto tie a double overhand knot on both TO sutures to secure the support22 down onto tissue, taking care to keep the support 22 centered. Thesurgeon is instructed to drive the knot down towards the anchor 42,keeping the support 22 centered, to firmly secure the posterior portionof implant for optimum urethral re-approximation. The surgeon isinstructed to tie additional overhand knots to lock the support 22 inplace, followed by trimming and discarding the removed excess suture. Inthis configuration, the base 60 of the support 22 is suspended by thesuture 24, with each suture 24 connected to an anchor 42 that is engagedin the muscle of one of the opposing obturator foramen. The surgeonselects the amount of tension desired in the lateral suspensionsupporting the base 60, for example by tying a suitable knot in thesuture 24 to fixate the base 60.

The arms 62, 64 are lifted to tension the support 22 against the bulbousspongiosis muscle. While holding the arms 62, 64 in tension, a thirdanchor is loaded into the introducer 28, and the introducer 28 isdirected through the incision to guide the anchor 42 under theperiosteum tissue but above the bone. Specifically, the surgeon isinstructed to place the tip of the introducer 28 perpendicular to thetissue and gently press down to contact the pubic bone, skive along boneaiming toward the patient's ipsilateral shoulder maintaining contact forapproximately 1.5 cm, then allow the needle to rotate away from thebone, followed by pushing the anchor 42 approximately 1 cm farther. Theintroducer 28 and the anchor 42 in the introducer 28 may be repositionedas desired by the surgeon. The surgeon is instructed to deploy theanchor 42 from introducer 28 using the thumb advance 56 and counterrotate to withdraw the introducer 28 leaving the anchor 42 in the densefibrous tissue of the periosteum. The surgeon is instructed to pull onthe suture 24 to seat anchor 42 in the tissue to ensure integrity of theanchoring. The suture 24 attached to the anchor 42 is pulled and theanchor 42 turns or toggles to fully engage the anchor 42 in a sidewaysorientation relative to the line of entry of the introducer 28 in theperiosteum tissue. The anchor 42 is engaged with the periosteum tissueto hold the support in tension against the urethral complex. The fourthanchor is loaded into the introducer 28, and introducer 28 is directedthrough the incision to guide the anchor 42 through into and under theperiosteum tissue on the contralateral side of the pubic symphysis ofthe patient. The surgeon is instructed to remove the conduit(s) from thesuture 24 followed by tying of a double overhand knot in the sutures 24to hold the support 22 in compression against the urethra. The knots aretightened to secure and stretch anterior portion of the support 22 overthe urethra to provide optimum compression. Tie additional knots to lockin place, trim and discard excess suture. The surgeon may performflexible cystoscopy to ensure appropriate coaptation of the urethra isachieved.

In this approach, the support 22 is secured and suspended by the sutures24 between the opposing obturator foramen and held in tension againstthe bulbous spongiosis muscle of the urethra by anchoring two anchors 42in the periosteum tissue on opposed lateral sides of the pubicsymphysis. If the surgeon decides that additional gathering of thesupport 22 over the urethra is desired, the surgeon will use theplication mechanism 70 to take up any slack in the mid-region of thesupport 22 to ensure appropriate elevation and support of the urethra.

FIG. 3 is a top view of the support material 22 superimposed over afour-arm support. In this example, the four-arm support has the shape ofthe Coloplast Virtue® Male Sling available from Coloplast Corp.,Minneapolis, Minn. known to be useful in treating male urinaryincontinence. The support material 22 has less material than this andother four-arm supports. The four-arm support includes a firsttransobturator arm (TO arm), a second TO arm, and a first pre-pubic armopposite a second pre-pubic arm. The four-arm support has a lateraldimension extending along the TO arms of about 18 inches and alongitudinal dimension extending between the pre-pubic arms of about 12inches. In contrast, the support material 22 has a base 60 with a widthor base dimension of between 0.5 inches to 1.25 inches, which is muchsmaller (about 17 inches smaller) than the material between the firstand second TO arms of the four-arm support. The first and secondpre-pubic arms 62, 64 of the support material 22 extend between 2-3inches, which is much shorter than the 12 inch extent of the pre-pubicarms provided by the four-arm support. It has been found that therelatively smaller support material 22 supports the male urethra as wellas the larger four-arm support when implanted through a single incisionand when secured by the anchors 26 and the system 20 described in thisdisclosure.

FIG. 4 is a perspective view of the introducer 28 a. The cannula 50extends from the handle 52 and terminates in an end 80. The button 56 ofthe ejection mechanism 54 is located on the handle. In one embodiment,the button 56 is curved in an arc that extends over an exterior portionof the handle 52, which allows the surgeon to manipulate the button 56when using the introducer 28 for placement of the anchor 42 in either atransobturator pass (deploying the anchor in TO tissue) or a pre-pubicpass (deploying the anchor in periosteum tissue). That is to say, whenthe introducer 28 is employed in a transobturator pass (e.g., either theright-hand side or left-hand side of the patient) the button 56 isconveniently located for operation by the thumb of the surgeon. When theintroducer 28 is then employed in a pre-pubic pass for placing pre-pubicarms, the extended and sculpted button 56 is likewise conveniently andergonomically located for one-handed operation by the surgeon.

The end 80 is formed on an end portion 82 of the cannula 50. In oneembodiment, the end portion 82 of the cannula 50 is formed to have aconstant outside diameter. In one embodiment, the end portion 82 of thecannula 50 is formed to have a tapering outside diameter that tapersfrom a first diameter D1 to a second diameter D2, where diameter D2 isless than diameter D1.

In one embodiment, the ejection mechanism 54 includes a wire/rod locatedinside of the cannula 50 and connected to the button 56. Movement of thebutton 56 moves the wire/rod within the cannula 50. When the anchor 42(FIG. 1) is inserted into end 80 of the cannula 50, movement of thebutton 56 in a distal direction ejects the anchor 42 in a distaldirection out of the cannula 50.

The cannula 50 may be straight or curved.

In one embodiment, the end portion 82 is formed as a circular arc allwithin the same plane such that the end portion 82 is neither helicalnor spiral.

In one embodiment, the end portion 82 is formed as a circular arc in ahelical spiral. For example, the end portion 82 extends between a firstsegment 84 and the end 80, and the helical spiral of the end portion 82is formed such that the end 80 is located a distance distal outward andaway from the first segment 84.

FIG. 5 is a perspective view of one embodiment of the introducer 28 awhere the end portion 82 is formed as a circular arc within the sameplane P. in one embodiment, the end portion 82 is oriented 90 degreesrelative to a straight segment 86 of the cannula 50.

FIG. 6 is a perspective view of one embodiment of the cannula 50 priorto inserting the anchor 42. The cannula 50 includes a bore 90 that issized to receive the body 44 of the anchor 42 and a slot 92 that issized to receive the tissue engagement fin 46 of the anchor 42. In oneembodiment, the end 80 of the cannula 50 is bent inward toward the bore90 to form an ejection ramp that is akin to a ski ramp on a ski jump. Inone embodiment, the end 80 of the cannula 50 forms a point that is bentinward, where the point is on a side of the cannula 50 opposite from alocation of the slot 92. The bent end 80 provides several advantages,including preventing the cannula 50 from digging into bone when thecannula 50 is inserted under periosteum tissue and encouraging theanchor 42 to lift and toggle away from the cannula 50 when the anchor 42is ejected from the cannula 50. In one embodiment, the bore 90 is acircular bore having a substantially constant inside diameter. Othergeometries are acceptable for the shape of the bore 90.

In one embodiment, the slot 92 is provided with side walls 94 a, 94 bthat are parallel one relative to the other. The anchor 42 is relativelysmall compared to the human hand. The tab 40 is provided to allow thehealthcare worker to handle the anchor 42 and insert the anchor into thecannula 50. After the body 44 of the anchor is inserted into the cannula50, the tab 40 is snapped off from the anchor 42. The tab 40 isdiscarded. The body 44 of the anchor 42 is sized to frictionally engagewith the bore 90 and the tissue engagement fin 46 is sized tofrictionally engage with the slot 92 such that the anchor 42 does notfall out of the cannula 50 until actively and intentionally ejected bythe surgeon operating the ejection mechanism 54 (FIG. 5).

It is desirable to frictionally engage the anchor 42 into the cannula 50of the introducer 28. The geometry of the bore 90 and the slot 92 can bemodified to encourage the frictional engagement between the cannula 50and the anchor 42.

FIG. 7 is a top view, FIG. 8 is a side view, and FIG. 9 is an end viewof one embodiment of a cannula 51 having a tapered outside diameter anda tapered slot 92′.

FIG. 7 is a top view of the cannula 51 having a slot 92′ modified toincrease frictional engagement with the anchor 42 illustrated in FIG. 1.

FIG. 7 illustrates one embodiment in which the slot 92′ is tapered. Theslot 92′ is tapered by having the side walls of the slot 92′ tapered atan angle T. In one embodiment, the angle T is 4 degrees and the sidewalls converge the width of the slot 92′ from 1.1 mm down to 0.890 mm.The tapered slot 92′ ensures positive engagement with the anchor 42. Inthis example, the inside diameter of the bore 90′ is 1.6 mm and theoutside diameter of the cannula is 2.2 mm.

FIG. 8 is a side view of the cannula 51, and FIG. 9 is an end view intothe bore of the cannula 51. In one embodiment, the outside diameter ofthe cannula 51 is tapered from a first outside diameter OD1 measured ata proximal portion down to a second outside diameter OD2 measured at adistal portion, where the first outside diameter OD1 is larger than thesecond outside diameter OD2. The pointed end of the cannula 51 is notbent to provide the ski slope that is provided by the cannula 50 (FIG.6).

FIG. 10A is a perspective view and FIG. 10B is a side view of the anchorassembly 26. The anchor 42 of the anchor assembly 26 includes alongitudinal midpoint M located in the middle of the length of theanchor 42 as measured on the longitudinal axis B between ends 102, 106.A leading end portion 100 of the anchor 42 extends from the midpoint Mto a leading end 102, and a trailing end portion 104 extending from themidpoint M to a trailing end 106. The leading end portion 100 isconnected to the trailing end portion 104 at the midpoint M. A verticalaxis A bisects the length of the anchor between the leading end 102 andthe trailing end 106 and thus intersects the midpoint M.

The anchor 42 has a geometric asymmetry where the anchor 42 has morearea on the leading end portion 100 (i.e., the left-hand side of theaxis A) then on the trailing end portion 104 (i.e., the right-hand sideof the axis A). The anchor 42 also has an asymmetric distribution ofmass relative to the axis A. In one embodiment, a longitudinal centralaxis B is drawn and intersects the vertical axis A. In one embodiment,the mass distribution of the anchor 42 is asymmetric relative to theaxis A (i.e., weighted more to the leading end portion 100) and is alsoasymmetric relative to the axis B (i.e., weighted more above the axisB). In this example, the center of mass CM is forward of the axis Atoward the end 102 and above the axis B. The center of mass CM of theanchor 42 is not necessarily located at the geometric midpoint M.

The tissue engagement fin 46 is located asymmetrically on the anchor 42relative to the midpoint M. In one embodiment, the tissue engagement fin46 is located along the leading end portion 100 of the anchor 42 toprovide the anchor 42 with a geometric asymmetry associated with theleading end portion 100. In one embodiment, the anchor 42 includes abarrel 110 located on the leading end portion of the anchor 42 toprovide the anchor 42 with an asymmetric mass distribution relative tothe midpoint M. The barrel 110, in combination with the tissueengagement fin 46, contribute to a distribution of mass for the anchor42 that is predominantly distributed forward in the anchor 42, forexample along the leading end portion 100. The barrel 110 and the eyelet48 provided in the tissue engagement fin 46, in cooperation with theasymmetric forward-biased mass distribution, allow the anchor 42 totoggle, or turn, to move to ensure engagement when inserted into tissue.

The tissue engagement fin 46 includes a leading edge 120 and a trailingedge 122, and the anchor 42 includes a leading surface 130 located onthe leading end portion 110 and the trailing surface 132 located on thetrailing end portion 104. In one embodiment, the insertion tab 40 isremovably secured to the leading edge 120 of the tissue engagement fin46. The insertion tab 40 includes a marker or other indicia 134 toprovide visual guidance to the surgical staff that is useful whenloading the anchor assembly 26 into the cannula 50 of the introducer 28(FIG. 1). After the body 44 and the barrel 110 of the anchor 42 areinserted into the cannula 50 of the introducer 28, the insertion tab 40is disconnected from (snapped off) from the anchor 42. The anchor 42 isretained within the cannula 50 and prepared for insertion into tissue.

FIG. 10B illustrates one embodiment in which the tissue engaging fin 46is triangular with a first side integrated in the leading end portion100 of the body 44, a leading side (e.g., leading edge 120) connectedbetween the leading tip 102 and a vertex V, and a trailing side (e.g.,trailing edge 122) connected between the vertex V and the trailing endportion 104 of the body 44, with the vertex V located off of thelongitudinal axis B.

When the anchor 42 is inserted into tissue, the surgeon is instructed toprovide a pulling force to the suture 24 (FIG. 1) that is engaged withthe eyelet 48, and this pulling force rotates the anchor 42 to engagethe leading edge 120, the trailing edge 122, and the trailing surface132 in a stable position within tissue.

The anchor 42 is both geometrically asymmetric and has an asymmetricmass distribution, both which encourage the anchor 42 to turn by whichthe leading end 102 is rotated in a clockwise (for example) manner toengage the edges 120, 122, and surface 132 with the tissue. The anchor42 is configured for insertion into periosteum tissue that covers bone.The bone provides a backstop or a hard surface that prevents the anchor42 from penetrating into the bone. The bone, however, also provides asurface that might discourage the rotation or toggle in of the anchor 42since the bone is substantially immovable. It has been discovered thatthe geometric asymmetry and the asymmetric mass distribution of theanchor 42 is well-suited to allow the anchor 42 to turn and toggle in ashort distance as the surgeon applies a pulling force to the suture thatis engaged with the eyelet 48. Other anchors having a geometric symmetryand a geometric mass distribution have been found to not turn, or turnless slowly and over a greater distance, which can have the effect ofthe anchor not fully engaging with the tissue and possibly having theanchor pull out of or exit its insertion point into the tissue. Incontrast, the anchor 42 has been discovered to provide rapid turning andtoggling that provides excellent tissue engagement over a shortengagement distance as the surgeon provides force to the suture 24 thatis engage with the eyelet 48.

FIG. 11 is a perspective view of the anchor assembly 26 oriented toillustrate a crush rib 140 located along a lower edge of the anchor 42on a side opposite from the tissue engagement fin 46. In one embodiment,the crush rib 140 extends from the leading end portion 100 back to thetrailing end portion 104. One suitable height of the crush rib 140 is ina range from 0.5-4 mm, preferably from 1-3 mm. The crush rib 140 isprovided to ensure a positive frictional engagement of the anchor 42with the cannula 50 (FIG. 1) of the introducer 28. The crush rib 140 isdeformable and configured to be pressed in toward the body of the anchor42 when the anchor 42 is inserted into a cannula. The crush rib 140occupies any excess space inside of the cannula, with the excessmaterial of the crush rib 140 compacted to fit inside the cannula in afriction-fit manner. The 1-3 mm height of the crush rib 140 allows therib to be compacted-to-size as it is inserted into the cannula.

Suitable materials for fabricating the anchor assembly 26 includepolymers in general, metal and metal alloys, composites, compositesreinforced with fibers, and other materials suitable for molding orextrusion. In one embodiment, the anchor assembly 26 is fabricated frompolypropylene. Other polyolefins or polymers are suitable.

The anchor 42 of the anchor simply 26 has a length extending from theleading end 102 to the trailing end 106 in a range from 2-30 mm,preferably 5-25 mm, and more preferably 10-20 mm. One suitable anchorlength has been determined to be about 11 mm from the leading end 102 tothe trailing end 106.

FIG. 12 is a side view of the anchor assembly 26, FIG. 13 is a bottomview of one embodiment of an anchor assembly 226, and FIG. 14 is a sideview of one embodiment of an anchor assembly 326. The anchor assembly 26provides the insertion tab 40 removably connected to the leading edge120 of the anchor 42. The anchor assembly 226 includes a perpendicularinsertion tab 240 secured to a side surface of the anchor 42. The anchorassembly 326 includes an insertion tab 340 located on the trailing edge122 of the anchor 42. The exterior surface of the insertion tabs 40,240, 340 can include a textured gripping surface such as a stippledsurface or another suitably structured surface that increases frictionwhen the surgical staff handles the anchor assembly with the glovedhand.

FIG. 15 is a perspective view, FIG. 16 is a top view, and FIG. 17 is abottom view of the anchor 42 without the insertion tab 40. The leadingedge 120 tapers to converge to a line 121 or narrow surface 121 thatallows the anchor 42 to more easily penetrate tissue.

The tissue engaging fin 46 extends away from the body 44. In oneembodiment, the tissue engaging fin 46 has a triangular shape with alongest side X of the triangle parallel with the longitudinal axis B-Bof the anchor 42, and shorter sides Y and Z meeting at an angle F, thethree sides X, Y, Z of the triangle defining a geometry of the tissueengaging fin 46.

The tissue engaging fin 46 is configured to grab in tissue and encouragethe anchor 42 to rotate for stabile engagement and anchoring withintissue. One embodiment provides the tissue engaging fin 46 with auniform width or thickness. In one embodiment, the interior portions ofthe triangle X-Y-Z are scalloped or thinned, such that the perimeter ofthe triangle X-Y-Z is thicker in width than the area inside of thetriangle X-Y-Z.

The crush rib 140 extends longitudinally along a portion of the bottomsurface of the anchor 42. The crush rib 140 is provided as a radiallyextending flange, where the flange has a width ranging between 0.1-0.5mm and a height in a range from 0.5-4 mm, preferably from 1-3 mm. In oneembodiment, the crush rib 140 includes a tapering leading edge and atapering trailing edge. The crush rib 140 is useful in retaining theanchor 42 in the cannula 50 of the introducer tool 28 (FIG. 1) untildeployment of the anchor 42 is initiated. The crush rib 42 issufficiently deformable when it is engaged with cannula 50 to allow theanchor 42 to be press-fit into the cannula 50 while also allowing theanchor 42 to be ejected from the tool.

FIG. 16 is a top view of the anchor 42. The leading edge 120 tapers toconverge to the line 121 or ridge 121.

In one embodiment, the leading edge 120 tapers or slopes from a pinnacleor vertex V of the anchor 42 towards the body 44 and the trailing edge122 tapers or slopes from the vertex/pinnacle of the anchor 42 towardsthe body 44. In one embodiment, the leading edge 120 includes slopingsurfaces 123, 125 extending from the line 121 toward first and secondside surfaces 127, 129 of the tissue engaging fin 46. The line 121 andthe sloping surfaces 123, 125 of the leading edge 120 are configured tofacilitate easy cutting or piercing through tissue during insertion androtation of the anchor 42 in the tissue. The configuration of theleading 120 including the 121 and the sloping surfaces 123, 125 providesthe leading edge 120 with a reduced thickness (width) relative to athickness of the fin 46 at the first and second side surfaces 127, 129,which aids the fin 46 in sliding through or piercing tissue.

In one embodiment, a top portion 131 of the tissue engaging fin 46 has agenerally cusped configuration with a base of the cusp located towardsthe trailing edge 122 of the fin 46 and with the two sides of thetriangle meeting on the line 121 of the leading face 52. The cusped topportion 131 is configured to help provide a smooth transition of theleading edge 120 between the line 121 and the first and second sidesurfaces 123, 125.

In one embodiment, the trailing edge 122 of the tissue engaging fin 46has a blunt configuration and can include a planar surface. The trailingedge 122 is configured to provide increased engagement with tissue suchthat the anchor 42 has improved resistance against extraction fromtissue once it is in implanted in position.

With reference to FIG. 17, the leading surface 120 of the anchor 42 isintegrated to and angles away from the barrel 110 to terminate at theleading end 102. The bottom view of the anchor 42 illustrates that theleading surface 130 is heart-shaped as the wider barrel 110 tapers tothe leading end 102.

In one embodiment, a width W3 of the tissue engaging fin 46 correspondsto the width W2 of the trailing end portion 104 of the body 44. In oneembodiment, the width W3 of the tissue engaging fin 46 is greater alongone or more of the sides X, Y, Z of the triangular shape (FIG. 15) thanat positions defined within the triangular area. That is to say, in oneembodiment a wall thickness of the tissue engaging fin 46 is thinner“inside” the triangle's bounds than at one or more of the edges of thetriangular shape.

In one embodiment, the tissue engaging fin 46 is superposed over theleading end portion 100 of the body 44 including the protruding barrels110. The protruding barrels 110 are formed as a pair of radial barrels110 extending from the body 44 in a radial direction perpendicular tothe direction of the fin 46.

In one embodiment, the tissue engaging fin 46 is offset towards theleading end 102 relative to the mid-point M of the body 30 (located onaxis A-A in FIG. 10). In one embodiment, the tissue engaging fin 46locates asymmetric to the mid-point M. In one embodiment, the tissueengaging fin 46 is offset such that an entirety of the tissue engagingfin 46 is located on leading end portion 100. In one embodiment, amajority but less than an entirety of the tissue engaging fin 46 locateson leading end portion 100. In one embodiment, the mid-point M of thebody 44 locates at a transition between the leading end portion 100 andthe trailing end portion 104. In one embodiment, the eyelet 36 forreceiving a length of suture extends through the entire width W3 of thetissue engaging fin 46.

FIG. 18A is cross-sectional view of the leading end portion 100 of theanchor 42 and FIG. 18B is cross-sectional view of the trailing endportion 104 of the anchor 42.

In one embodiment, the first and second protrusions 110 combine with theleading end portion 100 of the body to provide the tissue anchor 42 witha circular cross-section.

The tissue anchoring system 20 described above is useful for anchoringsupport material relative to tissue, particularly in treating urinaryincontinence. Embodiments provide placing the anchor 42 in tissue, whichcan include ligaments, fatty tissue, connective tissue and other softtissue in general. It has been discovered that support material usefulin treating male urinary incontinence can be implanted through a single(one and only one) incision by employing the introducer 28 and theanchor 42 described in this specification in placement of the anchor 42into periosteum tissue over the bone of the pelvis and other anchors inthe membrane of the transobturator foramen.

One approach to attaching a support 22 in treating male urinaryincontinence is made with reference to FIGS. 1 and 2. The base 60 of thesupport 22 is secured to the patient by engaging an anchor 42 in theobturator externus muscle of each obturator foramen and having thesuture 24 extend from each anchor 42 to the support 22. In this manner,the support 22 is suspended between the opposing obturator foramen. Thearms 62, 64 of the support 22 are lifted to tension the support againstthe bulbous spongiosis muscle, and while holding the arms 62, 64 intension, two other anchors 42 are secured in the periosteum tissue, oneon either side of the pubic symphysis of the patient. In this approach,the support 22 is secured and suspended by the sutures between theopposing obturator foramen and held in tension against the bulbousspongiosis muscle of the urethra by anchoring two anchors 42 between theperiosteum tissue and the bone on opposed lateral sides of the pubicsymphysis. The anchors 42 anchored between the periosteum tissue and thebone are placed as described below in FIGS. 19-21C.

FIG. 19 illustrates the cannula 50 of the introducer 28 inserted intosoft tissue along a cannula path and guided along the bone of the pelvisand into periosteum tissue. Neither the cannula 50 nor the anchor 42enter the bone. The anchor 42 has been inserted into the bore 90 andretained in the slot 92 with the insertion tab 40 (FIG. 1) removed. Thesuture 24 is engaged with the anchor 42 by the eyelet 48 and exitsthrough the incision made in the tissue. In this manner, the surgeon hascontrol of the anchor 42 by placing tension of the suture 24, and alsoby having the anchor 40 frictionally engaged within the cannula 50. Inone embodiment, the end 80 of the cannula 50 is bent upward toward thebore 90 to reduce the possibility of the end 80 digging into or gougingthe bone.

FIG. 20 illustrates the anchor 42 ejected a partial distance out of thebore 90 of the cannula 50 by the ejection mechanism 54. In oneembodiment, the ejection mechanism 54 is a piano wire connected to thebutton 56, where the wire is stiff in axial compression and suited forpushing the anchor 42 out of the cannula 50 and yet flexible in a radialdirection to allow the wire to negotiate the curvature of the introducerneedle or cannula 50. Suitable ejection mechanisms 54 include pianowire, braided wires, or flexible cables fabricated of metal or plastic.

With additional reference to FIG. 1, the button 56 of the ejectionmechanism 54 has been moved forward in a distal direction, which resultsin the wire pushing the rod forward in a distal direction. A surface ofthe rod pushes against the trailing edge 132 of the anchor 42 to ejectthe anchor 42 out of the cannula 50 and into the soft/connective tissue.The suture 24 and the proximal portion of the cannula 50 extend out ofthe incision toward the surgeon. The leading end 102 and the leadingsurface 130 of the anchor 42 are sized and configured to glide betweenthe periosteum tissue and over the bone (but not into the bone surface).The bent end 80 of the cannula 50 prevents the cannula 50 from digginginto the bone and lifts the anchor 42 away from the bone and beginsrotation or toggling of the anchor 42. The bent end 80 of the cannula 50provides a ramp 80, and movement of the anchor out of the cannula 50cause the anchor 42 to rotate away from the cannula path.

FIG. 21A illustrates the anchor 42 ejected out of the cannula 50. Thebent tip 80 directs the anchor 42 in an upward direction into theperiosteum tissue. The anchor 42 is rotated off of the cannula path (theanchor 42 is pitched upwards). In one embodiment, the anchor 42 has tworotational movements: one is rotated/pitched upwards off of the cannulapath and the second is rotated (or rolled) on the longitudinal axis ofthe anchor 42. The cannula 50 is removed from the tissue after theanchor 42 has been ejected. The surgeon controls the orientation of theanchor 42 by maintaining control of the suture 24. The additionalreference to FIG. 1, the suture 24 is engaged with the support material22 and includes the flattened break pad 30.

FIG. 21B illustrates the cannula 50 has been removed from the tissueleaving the anchor 42 in the periosteum tissue above the bone. Thesuture 24 extends away from the anchor 42 out of the incision by thecannula and back toward the surgeon.

FIG. 21C illustrates a top view of the anchor 42 in an orientation aftera pulling force has been applied to the suture 24. Pulling on the suture24 in a direction away from the patient, rotates the anchor 42 toposition a length of the anchor 42 transverse to the cannula path. Theanchor 42 is engaged with the periosteum tissue over the surface of thebone; in this sense, the anchor 42 is between the bone and the surfaceof the skin, thus located in the periosteum tissue.

The surgeon has directed a pulling forced onto the suture 24 to rotatethe anchor 42. The geometric asymmetry of the anchor 42 and theasymmetric mass distribution along the length of the anchor 42encourages the anchor to rotate into a stable configuration in which theleading edge 120, the trailing edge 122, and the training surface 132are engaged with tissue and resist further movement of the anchor towardthe opening formed in the skin by the cannula 50. The surgeon has thusforcefully engage the anchor 42 in the periosteum tissue into anorientation in which the anchor resists displacement or movement. Thesuture 24 extends the anchor 42 to the support material 22 (FIG. 1). Theanchor 42 is thus engaged with tissue and the suture 24 is engaged withthe support material 22. The surgeon has control of the anchor 42 withthe suture 24, and in preparation for tying a suitable suture knotseparates the suture 24 into two free ends by breaking the break pad 30.The suture 24 is tied in a suitable knot to retain the support material22 in the location desired by the surgeon.

It has been discovered that the anchor 42 engages with the periosteumtissue in such a forceful and durable manner that a polypropylene suture24, as commonly employed in treating incontinence, will fail and snapbefore the anchor 42 disengages with the tissue. That is to say, thepolypropylene suture 24 has been designed to be the weak link in thesystem 20 such that the anchor 42 will forcefully engage with periosteumtissue to allow the surgeon to apply as much force as desired andfixating the support material 22. The suture 24 will break before theanchor 42 can be pulled out of the tissue, which contributes to asuperior anchoring connection. The surgeon is familiar with the amountof force that can be applied to polypropylene suture.

The procedure described above places the anchor and the periosteumtissue that covers the pelvis. The system 20 is suited for placing theanchor 42 in other locations, for example through the membrane of theobturator foramen. In such a procedure, the cannula is directed throughthe single incision formed in the patient, around the ischial pubicramus and into the membrane covering the obturator foramen. One suitablesuch cannula includes the cannula 50 described in FIG. 5 having thecurved section 82. The ejection mechanism 54 is employed to deploy theanchor 42 into the membrane or muscle formed over the obturator foramen.The suture 24 is employed to fully engage the anchor 42 in the tissueprior to the surgeon fixating the support material 22 by tying a knotand the suture 24.

One suitable method for placing an anchor into tissue includes directingthe cannula 50 of the introducer 28 into the tissue; pushing the anchor42 out of the cannula 50; removing the cannula 50 from the tissue andleaving the anchor 42 in the tissue; applying a pulling force to thesuture 24 that is connected to the anchor 42 to engage the anchor 42with the tissue; breaking the bond that is formed in the suture 24 atthe break pad 30 to produce two free ends of the suture 24; and tying aknot in the suture 24 to fixate the anchor 42, or the anchor 42 and thesupport material 22, in position as desired by the surgeon andinstructed in the instructions for use of the system 20.

One advantageous embodiment of the system 20 includes providing thesurgeon improved control over when and where the anchor 42 is placed.For example, it is sometimes experienced that when an anchor isdelivered into tissue by an introducer that the tissue has aninsufficient ability to retain the anchor. This phenomenon isexperienced when the needle is directed into fatty tissue, after whichthe surgeon realizes that the fatty tissue will be unable toappropriately retain the anchor for treating male incontinence. Thesystem 20 provides a solution by allowing the surgeon to direct thecannula 50 into the tissue to determine if the tissue is suited forreceiving the anchor, and allowing the surgeon to remove both thecannula 50 and the anchor 42 if the surgeon determines the tissue is notideal for the application. The system 20 allows the surgeon to directthe cannula at another location in the tissue prior to ejecting theanchor 42 out of the cannula 50 with the ejection mechanism 54. Thesystem 20 provides the surgeon improved control in that the anchor 42does not leave the cannula 50 until the surgeon activates the ejectionmechanism 54.

One suitable method of anchoring a support material for treating maleurinary incontinence will now be described with reference to FIG. 1 inFIG. 2. A member of the surgical staff grasps the anchor assembly 26 bythe insertion tab 40 and inserts the anchor 42 into the cannula 50. Theinsertion tab 40 is subsequently removed from the anchor 42. The suture24 is engaged with the eyelet 48 of the anchor 42 and with the supportmaterial 22. The surgeon directs the cannula 50 to the tissue locationof interest and ejects the anchor 42 by activating the button 56 of theejection mechanism 54. The surgeon removes the cannula 50 from thetissue and applies a retraction force to the suture 24 that rotates andengages the anchor 42 with the tissue. The support material 22 is placedin the desired location, the break pad 30 is separated to provide thesuture 24 with two free ends, and the surgeon fixates a support material22 at the desired location. It should be noted that the surgeon also hasthe option to lightly tie a stay stitch to hold the support material 22in place until the other anchors are deployed.

One application of the above method includes forming one and only oneincision in the patient between the scrotum and the anus, and loadingthe anchor 42 a into the cannula 50. The insertion tab 40 is separatedfrom the anchor 42. The cannula 50 is inserted into the one and only onemidline incision and directed into the membrane of the obturatorforamen. The ejection mechanism 54 is manipulated to eject the anchor 42a into the membrane of the obturator foramen. The cannula 50 is removed,for example by following a pathway around a descending ramus and out ofthe incision. The base 60 of the support material 22 is located inferiorto the bulbar urethra and a stay stitch is placed with the suture 24. Asimilar approach is employed on the contralateral side of the patient toplace the anchor 42 b in the opposing obturator foramen membrane. Thesurgeon ties the suture 24 b to fixate the base 60 of the supportmaterial 22 at a location inferior to the bulbar urethra. With thesupport material 22 in its desired position, the surgeon returns tosuture 24A, removes the stay stitch, and ties a permanent knot to fixatethe base 60 of the support material 22.

The pre-pubic arms 62, 64 are elevated to a location superior to thebase 60 and a mark is made on the tissue with a marking pen to identifythe location of the pre-pubic arms 62, 64. It is desirable that thesupport material 22 elevates and compresses the tissue of the urethra,and in one embodiment the surgeon will place additional marks on thetissue at a location approximately 1 cm superior to each of thepre-pubic arms 62, 64 and 1 cm lateral and outside of each pre-pubicarms 62, 64 (i.e., the marks are “up and over” relative to the arms). Asuitable cannula is selected, and the anchor 42 c is loaded in thecannula. The cannula is directed into the periosteum tissue and theanchor 42 c is ejected from the cannula into periosteum tissue above thesurface of the bone of the pelvis. The cannula is withdrawn and a forceis applied to the suture 24 c to toggle and engage the anchor 42 cwithin the tissue. With the pre-pubic arm 62 placed in its desiredposition the surgeon will lightly tie a stay stitch in the suture 24 c.A similar approach will be employed on the contralateral side of thepatient in which the anchor 42 d is placed in the periosteum tissue by acannula of the introducer, after which the cannula is removed and theanchor 42 d is rotated or moved into engagement with the tissue byapplying a force to the suture 24 d. The pre-pubic arms 64 will beplaced in its desired position according to the instructions for useprovided with the system 20, and the surgeon will tie a permanent knotto fixate the pre-pubic arm 64. The surgeon confirms the location of theplacement of the pre-pubic arm 62, loosens the stay stitch in suture 24c, and ties a permanent knot in the suture 24 c to fixate the pre-pubicarm 62. In this manner, the pre-pubic arms 62, 64 are separated awayfrom the base 60 and fixated to elevate and compress the supportmaterial 22 against the urethra. If desired by the surgeon, theplication mechanism 70 is adjusted to remove slack from a central regionof the support material 22 after the base 60 and the pre-pubic arms 62,64 have been secured to tissue. The one and only one incision is closedin a suitable manner desired by the physician and the patient beginsrecovery.

FIGS. 22A-22K are schematic views of embodiments of a process forimplanting the tissue anchor system illustrated in FIG. 1 in a person totreat urinary incontinence.

In preparation for the surgery, the patient is reclined in a lithotomyposition, the sterile field is defined with appropriate draping, and theskin of the patient is suitably prepped according to the guidelines ofthe healthcare facility. The packaging containing the tissue anchorsystem 20 is opened and the instructions for use are made available, forexample on a back table in the surgical suite. The cannula 50 of theintroducer 28 is sized to place each of the anchors 42 of the system 20into tissue of the patient by accessing a single incision 145. Thesingle incision 145 is the one and only one incision formed in the skinof the patient. One useful incision is a midline incision formed betweenthe scrotum and the anus of a male patient to provide axis to the bulbarurethral complex. Some surgeons dissect the bulbous spongiosis muscle toaccess the urethra and the system 20 is appropriate for this approach.Other surgeons do not dissect the bulbous spongiosis muscle, but ratheraccess the urethra complex and the system 20 is also appropriate forthis approach. A dilator of some sort is typically used to force theincision 145 to an expanded position that provides access to the pelvictriangle. The dilator is not illustrated, but the incision isillustrated as an expanded circumferential area.

FIG. 22A is a schematic view of the anchor 42 b inserted into the slot92 of the cannula 50. The anchors 42 are located between the support 22and the patient, which allows the anchors to be fixated in tissue andthe support to cover the bulbar urethral complex. The suture 24 isprovided as a continuous loop of suture that extends through the eyeletof the anchor 42 b, a portion of the base 60 of the support 22, andterminates in the break tab 30 (see FIG. 1). The conduit 29 of FIGS. 1-2provided around a portion of the suture 24 to manage the suture array isoptional.

The anchor 42 b is somewhat small and can prove to be difficult tohandle by a person wearing surgical gloves. The insertion tab 40 isprovided to allow the anchor 42 b to be inserted into the slot 92 of thecannula 50. The bore 90 and the slot 92 are sized to engage with andretain the anchor 42 in the cannula 50. The insertion tab 40 issubsequently removed from the anchor 42 and discarded, leaving theanchor 42 secured within the cannula 50.

The following procedure will place the anchors 42 b, 42 a associatedwith the base 60 of the support 22 in separate opposing obturatorforamen (OF) of the patient. The anchor 42 b is inserted in thepatient's right side OF and the suture 24 b is allowed to trail out ofthe incision 145. The anchor 42 a is inserted in the patient's left sideOF and the suture 24 a is also allowed to trail out of the incision 145.The support 22 is position and the sutures 24 b, 24 a are tied off andterminated at the support 22. Thus, the base 60 of the support 22 issuspended by the sutures 24 b, 24 a implanted in the muscle of the OF.The anchors 42 c, 42 d attached to the pre-pubic arms of the support 22are subsequently attached to tissue of the periosteum, and each suture24 c, 24 d is secured after both anchors 42 c, 42 d are implanted, asdescribed below.

FIG. 22B is a schematic view of the anchor 42 b inserted into thecannula 50. The insertion tab 40 has been discarded. In some instances,the anchor(s) are pre-loaded into a cannula and do not have a tab 40that is discarded. Some embodiments of the cannula 50 include a distalend portion that is curved in the shape of a semicircle and suitablycurved for passage around the descending ramus for insertion into themuscle of the obturator foramen OF.

FIG. 22C is a schematic view of the right side introducer 28 a (relativeto the patient) inserted through the incision 145 and directed on a patharound the descending ischial pubic ramus (or, ischial ramus IR). Theend 80 of the cannula 50 follows a path from the incision 145, aroundthe IR and penetrates the membrane M of the obturator foramen OF to alocation of the obturator internus muscle. The button 56 is activated topush the anchor 42 b out of the cannula 50 and into the obturatorinternus muscle. The introducer 28 a is removed from the incision 145.The surgeon applies a force to the suture 24 to toggle the anchor 42 bto ensure that the anchor is fully engaged with the obturator internusmuscle. The base 60 of the support 22 is directed through the incision145. The suture 24 is connected to the anchor 42 b and passed throughthe support 22 and hangs freely out of the incision 145. The surgeonmight choose to fixate the base 60 using the suture 24 and the anchor 42b, however experience has indicated that fixation of the base 60 ispreferable after placing the second anchor 42 a.

FIG. 22D is a schematic view illustrating the base 60 of the support 22located in one desirable position with the second anchor 42 a insertedinto the cannula 50 of the left-hand introducer 28 b. Anchor 42 a willbe inserted on the patient's left hand side using the introducer 28 bthat is provided with a curvature that is opposite from the curvature ofintroducer 28 a (the right side introducer). Insertion tab 40 has beenremoved from the anchor 42 a.

FIG. 22E is a schematic view of the left side introducer 28 b insertedthrough the incision 145, around the descending IR, and through themembrane M covering the obturator foramen OF. The button 56 is moved toeject the anchor 42 a out of the cannula 50 and into the obturatorinternus muscle. The introducer 28 b is removed. The surgeon pulls onthe suture 24 to toggle the anchor 42 a in a sideway orientation withinthe muscle and to ensure that it is fully engaged with the obturatorinternus muscle. The suture 24 is allowed to descend through the support22 and the incision 145 until fixated by the surgeon.

Regarding one process of anchoring the anchor to tissue, and as thesteps are illustrated in FIG. 22E, the second anchor is inserted into abore of a separate second cannula; the separate second cannula isinserted into the incision and along a second cannula path into tissueof an obturator foramen; the second anchor is ejected out of the bore ofthe separate second cannula and into the tissue of the obturatorforamen; the second suture is pulled in a direction away from thepatient to rotate the second anchor to position a length of the secondanchor transverse to the second cannula path; and the second continuoussuture loop is broken, allowing a second knot to be tied with the secondsuture to fixate the support in the patient.

FIG. 22F is a schematic view of the support 22 guided through theincision with the base 60 maintained in a lateral orientation betweenthe opposing obturator foramen OF. The surgeon locates a desiredorientation for the base 60 and terminates the suture 24 connected tothe anchor 42 b and terminates the suture 24 connected to the anchor 42a. The surgeon applies an appropriate level of tension to the base 60while terminating the sutures 24. In this way, the base 60 is suspendedbetween the sutures 24 and a respective one of the anchors 42 b, 42 a.The pre-pubic arms 62, 64 are elevated to either side of the pubicsymphysis PS.

FIG. 22G is a schematic view of the anchor 42 d loaded into the cannula50 of the left side introducer 28 b. The insertion tab 40 has beenremoved and discarded. The procedure allows for placement of thepre-pubic arm anchors 42 c, 42 d with either the right side introducer28 a or the left side introducer 28 b, as determined by the preferenceof the surgeon. At times, the surgeon will simply maintain use of themost recently used introducer (in this case, introducer 28 b from FIG.22E); at other times, the most recently used introducer is returned toone of the surgical staff and the other introducer is employed.

FIG. 22H is a schematic view of the introducer 28 b inserted through theincision 145 to attach the pre-pubic arm 62 to the left-hand side of thepatient. The end 80 of the cannula 50 is inserted through the periosteumtissue PT. The end 80 of the cannula 50 is bent/sloped or otherwiseconfigured to allow the tip of the introducer to slide along the boneand avoid digging into the bone under the periosteum tissue PT. Thebutton 56 is manipulated to eject the anchor 42 d out of the cannula andunder the periosteum tissue PT and on top of the bone. The introducer 28b is removed from the incision. The surgeon applies a pulling force tothe suture 24 that is connected the anchor 42 d, and this force togglesand rotates the anchor 42 d into a broadside-on position that fullyengages the anchor 42 d with the periosteum tissue PT. the suture 24 dextends from the implanted anchor 42 d, through the pre-pubic arm of thesupport 22, and out of the incision for subsequent fixation.

Regarding one process of anchoring the anchor to tissue, and as thesteps are illustrated in FIG. 22H, another anchor is inserted into thebore of the same cannula 28 b that was employed in placing an anchorinto the tissue of the obturator foramen, and this other anchor isinserted in the cannula and into the incision and along a second cannulapath into periosteum tissue. This other anchor is ejected out of thebore of the cannula and into the periosteum tissue. The other sutureattached to the other anchor is pulled in a direction away from thepatient to rotate the other anchor to position a length of the anchortransverse to the second cannula path. The other continuous suture loopis broken to allow a knot to be tied to fixate the support over theperiosteum tissue.

FIG. 22I is a schematic view of the base 60 of the support 22 suspendedbetween the obturator foramen OF with the pre-pubic arm 62 secured tothe periosteum tissue PT on the left-hand side of the patient by theanchor 42 d. A fourth anchor 42 c is inserted into the cannula 50 of, inthis instance, the introducer 28 a. Again, the insertion tab 40 has beenremoved from the anchor 42 c and discarded.

FIG. 22J is a schematic view of the introducer 28 a inserted through theincision to fixate the pre-pubic arm 64 on the right-hand side of thepatient. The end 80 of the cannula 50 is directed through the periosteumtissue PT. The end 80 of the cannula 50 will slide along the surface ofthe bone. When suitably placed between the periosteum tissue PT and thebone, the button 56 is pushed forward to eject the anchor 42 c out ofthe cannula 50. The introducer 28 b is removed from the incision. Thesurgeon applies a tension to the suture 24 to toggle, rotate, and engagethe anchor 42 c within the periosteum tissue PT. At this point in theprocess, two anchors 42 d, 42 c are attached in the two pre-pubic armsand the associated sutures 24 d, 24 c extend from the anchors 42 d, 42 cfreely out of the incision 145.

The surgeon elevates both of the pre-pubic arms 62, 64 in tensionagainst the fixed base 60 and terminates the sutures 24 d, 24 c.

FIG. 22K is a schematic view of the support 22 suspended between theobturator foramen OF and the anchors 42 a, 42 b and fixated to theperiosteum tissue PT by anchors 42 c, 42 d. The support 22 has beenimplanted through a single (one and only one) incision. The implantedanchors 42 combine with the sutures 24 to hold the support 22 in placeand to elevate and compress the bulbar urethral complex in treating maleurinary incontinence.

Some introducers and anchors suitable for use with the system 20 includean introducer provided with a needle, and an anchor having a recess thatis sized to fit on and over the needle.

FIG. 23 is a side view of one embodiment of a system 400 including anintroducer 402 provided with a needle 404 and an anchor 406 pinned ontoand over the needle 404.

FIG. 24 is a side view of the needle 404 and the anchor 406 illustratedin FIG. 23. The needle 404 includes a pin 408 and the anchor 406includes a recess 410 that is sized to receive the pin 408. A suitablesuture is engaged with the anchor 406 and operates in a manner that issimilar to the anchor 42 described above.

FIG. 25 is a side view of the anchor 406 engaged with the pin 408 of theneedle 404.

The anchors described above include some aspect of an asymmetricgeometry and some aspect of an asymmetric distribution of mass along alength of the anchor. It has been discovered that other anchors shapesand sizes are also suitable.

FIG. 26-FIG. 33 illustrate anchors provided with symmetry relative to avertical line drawn through a midpoint of the length of the anchor.These anchors have an asymmetric mass distribution relative to alongitudinal axis of the anchor. For example, the anchors illustrated inFIG. 26-FIG. 33 are symmetric relative left and right to the eyeletprovided for engagement with the suture. The anchors illustrated in FIG.26-FIG. 33 are pre-formed to include a recess sized for placement over apin or needle of an introducer. These laterally symmetric anchors couldalso be configured for placement into a cannula, similar to the cannula50 described above.

FIG. 34-FIG. 36 illustrate anchors having a geometric asymmetry and anasymmetric distribution of mass relative to the eyelet. The anchorillustrated in FIG. 34 has a single tissue engagement fin, and theanchor illustrated in FIG. 35 has multiple tissue engagement fins. FIG.36 illustrates an anchor having an eyelet and no fin.

FIG. 37-FIG. 38 illustrate solid anchors having a geometric symmetryrelative left and right to the eyelet and more mass on the longitudinalside of the eyelet than on the side of the anchor opposite of theeyelet.

FIG. 39 is a perspective view of one embodiment of an anchor suitablefor use with the system 20 described above.

FIG. 40 is a perspective view of one embodiment of an anchor suitablefor use with the system 20 described above. The anchor illustrated inFIG. 40 includes a flange 500 that is configured to drag as the anchoris pulled through tissue, which encourages rotation and engagement ofthe anchor in the tissue.

FIG. 41 is a perspective view of one embodiment of an anchor suitablefor use with the system 20 described above.

FIG. 42 is a perspective view of one embodiment of an anchor suitablefor use with the system 20 described above.

FIG. 43 is a perspective view of one embodiment of an anchor suitablefor use with the system 20 described above. The anchor illustrated inFIG. 43 is has an arcuate body provided with a curvature.

FIG. 44-FIG. 46 are perspective views of anchors suitable for use withthe system 20 described above. Each of the anchors illustrated in FIG.44-FIG. 46 include multiple tissue engagement flanges. The anchorillustrated in FIG. 44 is bullet-shaped for ease of insertion intotissue and has multiple flaps that are configured to provide excellentengagement with tissue.

A variety of suitable suture management devices are described, includingthe break pad 30 illustrated in FIG. 1, in addition to buttons, slidingknots, fixed knots, destructive bonds, smash bonds, and other suturemanagement devices.

FIG. 47 illustrates a suture engaged with an anchor, with a suturemanagement device engage between a top segment and a bottom segment ofthe suture.

FIG. 48 is a perspective view of a suture engaged through an eyelet ofan anchor, with the suture provided with a sliding knot 600 and asliding fixation mechanism 602. After placement of the anchor, thesliding fixation mechanism 602 is slid along the suture to hold asupport material in place. The sliding knot 600 is slid down the sutureinto engagement with the fixation mechanism 602, which prevents thesliding fixation mechanism 602 from becoming loose.

Other Approaches Employing Anchor Assembly 26

The following disclosure describes other approaches in which the system20 described above could be used in treating urinary incontinence. Thefollowing disclosure cooperates with and complements the disclosureabove and forms a part of this specification.

The following disclosure illustrates a different set of FIG. 49-FIG. 77describing an introducer for delivering an anchor 42 attached to asuture 24. All of the following procedures described in the followingFIG. 49-FIG. 77 can be suitably achieved by employing the anchorassembly 26 and the introducer 28 as described above. The shape of thesupport material is suitably selected from the support material 22described above in FIG. 1, or with the support materials described belowin FIG. 53-FIG. 54, FIG. 60-FIG. 65, FIG. 666-FIG. 71B, FIG. 76, or FIG.77.

FIG. 49 is a perspective view of one embodiment of a surgical system 20including a dual-ended introducer, with each end having one of thecannulas 50 described above that is sized for use with the anchor 42.

The introducer includes two cannulas 50 extending from a handle. Thehandle includes a gripping surface formed on at least one side of thehandle. It is acceptable to provide the handle with several grippingsurfaces or with no gripping surfaces. During a suturing procedure, theanchor 42 is loaded into the opening of the cannula 50 and the surgeongrips the handle and directs the pointed distal end of the cannula 50 toa targeted tissue landmark. Force delivered to the handle in a distaldirection will drive the pointed distal end of the cannula 50 into thetissue, such that a subsequent withdrawal of the introducer in aproximal direction will allow the introducer to exit the tissue. Theanchor 42 is engaged with and deposited in the tissue after the cannula50 is withdrawn.

In one embodiment, the introducer includes a pair of cannulas, includinga second cannula 50 having the same pointed distal end and an openingformed in the cannula 50. The second cannula 50 is provided to receive asecond, separate anchor 42.

Suitable materials for fabricating the anchor 42 include plastics, ormetal, or sintered material. One suitable material for fabricating theanchor 42 is polypropylene. Another suitable material for fabricatingthe anchor 42 is a bioabsorbable polymer that configures the anchor 42to be absorbed into the body over a period of several weeks.

Suitable materials for fabricating the length of suture 24 includebio-inert components that do not bioabsorb, or bioabsorbable componentsthat are configured to be absorbed or resorbed by the body. One suitablematerial for fabricating the length of suture 24 is polypropylene. Othersuitable materials for fabricating the length of suture 24 includedissolvable sutures available from Ethicon™, a J&J Company located inSomerville, N.J., and include Monocryl™ (polyglycaprone 25) sutures,coated Vicryl™ (polyglactin 910) sutures, Ethicon Plus™ Sutures, orpolydioxanone sutures as examples.

Suitable materials for fabricating the cannula 50 and include plasticsor metal. One suitable material for fabricating the cannula 50 isstainless steel. Other suitable materials are acceptable.

The anchor 42 is useful for fixating a support material within apatient's body. The introducer is sized to place the anchors 42 througha single incision and into the periosteum tissue that covers the pubicbone, examples of which are described below.

FIG. 50 is a schematic view of one embodiment of a support 700attachable to a pelvis of a patient. FIG. 50 provides an anterior viewof the pelvis with the sacrum S located in a posterior portion of theview, with the pubic symphysis PS centered relative to the pubic bonePB, and an obturator foramen OF on each bilateral side of the pelvis.Each obturator foramen OF provides an opening or a window that iscovered by a membrane M. Nerves and arteries traverse the upper reachesof the obturator foramen OF. The membrane M generally includes severallayers of muscle and at least one layer of ligament-like tissue thatconnects the muscles in the membrane M to the pelvis. The ischial pubicramus IR is located inferior to the pubic bone PB and the obturatorforamen OF.

The support 700 is provided to elevate and compress the male urethra andincludes a body 702, a first arm 704 extending from the body 702, asecond arm 706 extending from the body 702, and a pre-pubic portion 708that is oriented in a generally orthogonal position relative to the arms704, 706. The illustrated embodiment is a two-arm device.

Suitable materials for fabricating the support 700 include porousmaterials that allow tissue ingrowth throughout the support structure toanchor the support 700 in the body after implantation and healing.Suitable such porous materials include autograft material (the patient'sown tissue), allograft material (tissue from a cadaver), xenograftmaterial (tissue from another species), or synthetic materials such aswoven fabrics, knitted fabrics, meshes, nonwoven fabrics, meshes,fibrillated fibers, or spun and fibrillated fibers that are providedwith voids (pores) configured to allow tissue ingrowth into the support700. The pores are generally larger, on average, than 75 μm.

The support 700 is attached to the pelvis with each arm 704, 706inserted into one of the respective obturator foramen OF, and with thepre-pubic portion 708 attached to the periosteum tissue that lines theexterior of the pubic bone PB. The following surgical procedure is oneexample of the suitable implantation of the support 700 into a malepatient.

The patient is positioned on a surgical operating table in a lithotomy,or modified lithotomy position, and is anesthetized. A vertical midlineperineal incision is formed between the scrotum and the anus. Tissue isdissected to expose the bulbous muscle around the urethra. A suitabletool is used to direct the arm 704 into and through the first obturatorforamen OF, and this procedure is repeated on the contralateral side toplace the arm 706 into and through the second obturator foramen OF.

One suitable approach of placing the arms 704, 706 through the obturatorforamen OF is described as an “outside-in” approach. The outside-inapproach includes directing a needle or other device through the skin ofthe groin area of the patient external of the obturator foramen OF alonga curved path through the membrane M and around the ischial pubic ramusR such that the tool exits the midline perineal incision. One of thearms 704, 706 is attached to the tool, and the tool is withdrawn alongits curved pathway back around the ischial pubic ramus IR, through themembrane M, out of the obturator foramen OF, and out of the skin at thegroin area. In this manner, each arm 704, 706 is directed through andplaced in one of the obturator foramen OF. The arms 704, 706 are trimmedto a subcutaneous level. A holding stitch is placed to hold the arm 704,706 relative to the groin tissue, as determined by the surgeon.

A different approach is the “inside-out” approach in which the needle ortool is coupled to the support and directed from the perineal incision(inside) outward to the skin at the groin area (outside). Placement ofthe arms 704, 706 with the inside-out approach is also acceptable.

One acceptable single incision approach includes the formation of asingle (exactly one) incision in the urogenital triangle. Tissue isdissected distal the incision to access the urethra and the pelvis. Thearms 704, 706 of the support 700 are directed into the single incisionand anchored to the membrane M of the obturator foramen OF, for examplewith the anchor 42 as described above in FIGS. 22A-22K. The pre-pubicportion 708 is inserted into the single incision and fixed to theperiosteum tissue over the pubic bone PB by the anchor 42 as deliveredby the introducer. In this manner, a treatment for urinary incontinenceis provided to the patient by forming exactly and only one incision andimplanting the support 700 through that single incision.

FIG. 51 is a schematic view of the surgical system employed to fixatethe pre-pubic portion 708 of the support 700 to the periosteum tissue ofthe pubic bone PB. The cannula 50 of the introducer is inserted into theperineal incision and directed to the pubic bone PB anterior to thepelvis.

In one suitable approach, the anchor 42 is driven through the materialof the support 700 and into the periosteum tissue that covers the pubicbone PB. The cannula 50 pierces the periosteum tissue and slides alongthe bone of the pelvis without entering or penetrating the bone. Theanchor 42 is engaged under the periosteum tissue and the suture 24extends through the support 700 out through the perineal incision. Thesurgeon, depending upon surgeon preference, will place at least oneanchor 42 through the pre-pubic portion 708 an each side of the pubicsymphysis PS. The suture 24 extends from each anchor out through theperineal incision and is available for subsequent tying or othertermination.

In a different suitable approach, the anchor 42 is loaded into theintroducer and the cannula 50 is introduced in the perineal incision upto the pubic bone PB anterior to the pelvis. The introducer is employedto drive the anchor 42 under the periosteum tissue of the pubic bone PBand the cannula 50 is withdrawn through the perineal incision. Thesuture 24 trails behind the anchor 42 and exits the body at theincision. An end of the suture 24 is inserted through the pre-pubicportion 708 of the support 700, and the pre-pubic portion 708 is guidedalong the suture 24, through the incision, and up to the pubic bone PB.Thereafter, the suture 24 is tied or terminated to hold the pre-pubicportion 708 against the pubic bone.

FIG. 52 is a schematic view of the anchor 42 secured to the periosteumtissue and the support 700 secured to the suture 24. In one embodiment,the system 20 described above includes a stopper 150 that is attached tothe suture 24, where the stopper 150 is configured to slide along thesuture 24 and direct the support 700 into the patient's body and againstthe tissue. In one embodiment, the stopper 150 has a first orifice 152and a second orifice 154. One or more of the anchors 42 is engaged withthe periosteum tissue of the pubic bone PB, and a first end 156 of thesuture 24 extends from the anchor 42 through the first orifice 152, anda second end 158 of the suture 24 extends to the second orifice 154. Thestopper 150 slides along the suture 24 and is operable to push orotherwise deliver the support 700 against the pubic bone PB. In oneembodiment, a slip knot 160 or other termination device is provided totie the suture 24 against the stopper 150 after the stopper 150 and thesupport 700 has been delivered to the pubic bone PB. The stopper 150 islocated between the anchor 42 and the slip knot 160.

Suitable materials for fabricating the stopper 150 include plastics ormetal. One suitable material for fabricating the stopper 150 includespolypropylene. Another suitable material for fabricating the stopper 150includes stainless steel. In one embodiment, the stopper 150 isfabricated to be bioabsorbable.

FIG. 55 is a schematic view of two anchors 42 secured to tissue T andcoupled with a suture 170. The anchors include a first anchor 42 a and asecond anchor 42 b. The anchors 42 are engaged with the tissue T, forexample through the use of the introducers described above. A suture 170is provided having a first end 180 terminated to the eyelet of theanchor 42 a, a mid-portion 182 of the suture located between the firstanchor 42 a and the second anchor 42 b, and a portion 184 of the suturein sliding engagement with the eyelet of the second anchor 42 b. A freeend 186 of the suture 170 is provided, and pulling on the free end 186of the suture 170 cinches the mid-portion 182 of the suture between thefirst anchor 42 a and the second anchor 42 b. In one embodiment, a slideknot 190 or sliding engagement feature 190 is coupled to the suture 170and is so configured to secure or lock the mid-portion 182 of the suturein a desired position relative to the anchors 22. The slide knot 190operates to cinch the suture 170 tightly against the support 700 (FIG.51) against the tissue T.

Some male incontinence treatment devices have several arms, includingsome form of arms that traverse the obturator foramen and other armsthat are implanted anterior to the pubic bone (called pre-pubic arms).The pre-pubic arms are tunnelled anterior to the pelvis and exit theskin of the abdomen.

In contrast, embodiments of the system described above provide a supportwith two arms that are A) secured to the periosteum alongside theobturator foramen or B) secured to the membrane M covering the obturatorforamen or C) secured through the obturator foramen and a system 20 toattach a portion of the support directly and efficiently to theperiosteum tissue over the pubic bone. The system obviates the use ofadditional pre-pubic arms that are tunnelled under and affixed to theskin. The system is easier to implant and reduces the amount of timethat the patient is in the operating room.

FIGS. 54-62 are schematic views illustrating embodiments of a method ofanchoring a support material to tissue.

FIG. 54 is a schematic view of a pelvis. The view has been simplified bynot illustrating certain extraneous aspects of human anatomy such ascertain of the organs and certain of the muscle and other connectivetissues. The view is oriented from a location anterior to the pelvis andshows the sacrum S in the background and the pubic symphysis PS in theforeground.

The patient is prepared for surgery according to the accepted proceduresof the hospital or clinic, suitably anesthetized, and placed in alithotomy position with the feet elevated above the level of the hipsand the perineum at the edge of the surgical table. An incision isformed in the urogenital triangle of the patient. The urogenitaltriangle is that region on a female patient where a base leg of theurogenital triangle is oriented in a horizontal manner between thevagina and the anus, and the pair of generally equilateral legs of theurogenital triangle extending from the base leg meets at an apex abovethe vertex of the labia. The urogenital triangle is that region on amale patient between the scrotum and the anus. Tissue is dissected awayfrom the incision to access the urethra, and in some procedures, theischial pubic rami IR.

The method of anchoring a support material to tissue includes firstforming the incision in the urogenital triangle of a male patient or afemale patient for access to the pelvic anatomy. Thereafter, one of theanchors 42 is placed in the tissue (i.e., not in the bone) leaving thesuture 24 trailing out of the incision. The support is delivered alongthe suture 24 in a distal direction (e.g., along an inward direction) tothe location of the anchor 42. The suture 24 is terminated to thesupport to fixate the support inside the patient. Consistent with thisdescription, the anchor 42 is inserted into the cannula 50 of theintroducer. The introducer is now readied to affix the anchor 42 to thetissue.

FIG. 55 is a schematic view of the leading end of the cannula 50inserted into and guided through the incision. The surgeon palpates forthe surface of the pelvis and thereafter pushes the leading end of thecannula 50 into the periosteum tissue PT of the pelvis until the anchor42 is engaged with (e.g., under) the periosteum tissue PT. Periosteumtissue is a thin sheet of dense fibrous connective tissue that isattached at the outer surface of all bones. The periosteum tissue PT isrepresented as a hashed area and it is understood that the periosteumtissue PT covers the exterior of the boney pelvis.

FIG. 56 is a schematic view of the anchor 42 engaged with the periosteumtissue PT. The cannula 50 (FIG. 55) has been withdrawn from an incisionleaving the anchor 42 embedded or engaged with the periosteum tissue PT.The anchor 42 is under the periosteum tissue PT and over (or above orsuperior) to the bone of the pelvis. The anchor 42 is not inserted intothe bone of the pelvis. The suture 24 is connected to the anchor 42, anda portion of the suture 24 extends out of the incision and is available(for example as a conduit) to allow the surgeon to deliver supportmaterial along the suture 24 to the anchor 42. In this manner, since theanchor 42 is embedded in the periosteum tissue PT a support can bedelivered to the anchor and fixed against nearly any bone in the body.Thus, the surgeon need not “aim” for the obturator foramen or otherspecific tissue landmark; the surgeon simply anchors the anchor 42 intoperiosteum tissue PT.

FIG. 57 is a schematic view of support material 202 coupled in slidingengagement with the suture 24. The support material 202 is illustratedin a generalized form. The support material 202 includes an area of asupport. In some embodiments, one or more arms or one or more legsextend from the area of support material 202. In some embodiments, thesupport material 202 is just an area of material without arms or legs,for example a trapezoid or a rectangle of material that allows thesurgeon to trim a desired shape (i.e., a “trim-to-size” support). Thesupport material 202 is acceptably fabricated from the material of thesupport 700 described above.

The surgeon secures the support material 202 to the suture 24, forexample by guiding the suture 24 through a pore or other opening of thesupport material 202. If the support material is a solid and does nothave an opening, the surgeon employs a needle to direct the suture 24through the support material 202. The portion of the suture 24 thatextends out incision allows the surgeon to conveniently couple thesupport material 202 to the suture 24 outside of the patient's body.

FIG. 58 is a schematic view of the support material 202 having beendelivered along the suture 24, through the incision, in a distaldirection to the patient's pelvis. The surgeon uses an instrument, orperhaps a finger, to guide the support material 202 through the incisioninward toward the pelvis. The anchor 42 is buried or otherwise implantedinto the periosteum tissue PT, and the support material 202 is proximalto the anchor 42.

FIG. 59A is a schematic view of the support material 202 located betweenthe anchor 42 and a stopper 210. The support material 202 has beendelivered through the incision to the pelvis of the patient, and thestopper 210 is configured to engage with the suture 24 and fixate thesupport material 202 against the pelvis. The anchoring of the supportmaterial 202 to the pelvis will support the urethra of the patient. Thestopper 210 is configured such that sliding the stopper 210 along thesuture 24 will forcibly affix the support material 202 to the patient.In one embodiment, the stopper 210 is configured for one-directionalsliding along anchor 42, for example, only in a direction into thepatient. The stopper 210 includes fingers that prevent the stopper 210from moving in the direction out of the patient's body.

FIG. 59B is a schematic side view of the stopper 210 and the fingers212. The fingers 212 are deflected to diverge away from the patient'sbody, which allows the stopper 210 to move along the suture 24 in thedirection into the patient's body as indicated by the arrows. Thestopper 210 is configured as a unidirectional stopper that is allowed tomove in one direction along the suture 24. Attempted movement of thestopper 210 in the opposite direction causes the fingers 212 to impingeagainst the suture 24, which prevents movement of the stopper 210 of thepatient's body.

FIG. 60 is a schematic view of one embodiment of a stopper 220 providedto secure the support material 202 within the patient. The stopper 220,also referred to as a button 220, includes a first orifice 222 and asecond orifice 224. The suture 24 includes a first strand 25 that isinserted through the first orifice 222 and a second strand 27 that isinserted through the second orifice 224. The button 220 is operable toslide along the suture 24 as the strands 25, 27 slide through theorifices 222, 224, respectively. In this manner, the button 220 isoperable to be delivered through the incision and into the patient. Itis desirable to secure the button 220 against the support material 202.In one embodiment, the first strand 25 is tied to the second strand 27to provide a slip knot 226. Pulling on the free end (e.g., strand 25)drives the slip knot 226 in a distal direction into the patient untilthe slip knot is secure against the button 220. Eventually, that portionof the suture 24 that is proximal of the button 220 is tied or otherwiseterminated, and the excess suture 24 is removed by the surgeon.

FIG. 61 is a schematic view of the support material 202 secured to thepatient and located between anchor 42 and the stopper 220 (or button220). The excess portion of the suture 24 has been removed. Otherportions of the support material 202 may also be secured to other tissueof the patient, for example in a bilateral manner by using theintroducer and the anchor 42 as described above.

FIG. 62 is a schematic view of the support material 202 secured to theperiosteum tissue PT of the patient on either lateral side of the pubicsymphysis PS. The support material 202 is secured or fixated at twolocations, a left side location (relative to the view of FIG. 64) and aright location. Each fixation location has the support material 202positioned between the anchor 42 lodged in the periosteum tissue and thestopper 220, with the excess portion of the suture 24 removed. When thesurgeon is satisfied that the support material 202 is appropriatelyplaced and fixated, the incision is closed.

In the case of a male patient, the support material 202 has atrapezoidal shape that is sized to support the bulbar urethral complex230 (muscle and other tissue) and elevate and support the male urethra.The support material 202 in the case of the male patient is typicallysecured in more than two bilateral locations to allow substantialsupport and elevation to the longer male urethra.

In the case of a female patient, the support material 202 has arectangular (e.g., “sling”) shape of about 1 cm wide by 5-10 cm longthat is sized to extend across the descending rami to support the short(˜2 cm) female urethra 230. The support material 202 in the case of thefemale patient is typically secured in two bilateral locations toprovide support without compression (or with reduced compression to theurethra).

FIGS. 63-68 are schematic views illustrating embodiments of a method ofanchoring a support 310 to tissue. The support 310 is a rectangularsling-style of support as is appropriate for treating female urinaryincontinence.

FIG. 63 is a schematic view of the system employed to secure the support310 to the pelvis. The system includes the first anchor 42 a insertedinto the first cannula 50, the second anchor 42 b inserted into thesecond cannula 50, and a length of suture 300 connected between thefirst anchor 42 a and the second anchor 42 b. The suture 300 is providedto slide relative to the first anchor 42 a and includes a stopper 302that fixes the suture 300 in a position selected by the surgeon.

Aspects of the surgical procedure include forming an incision in aurogenital triangle, for example in the upper wall of the vagina anddissecting tissue to identify each of the two descending ischial pubicrami IR. The support 310 is inserted in the incision after suitabledissection of the tissue. The system is employed to anchor or fixate thesupport 310 in a position inferior to (under) the urethra U.

The anchor 42 a is loaded into the first cannula 50 and the cannula 50is introduced into the incision.

FIG. 64 is a schematic view of the support 310 relative to the pelvisand illustrates the first cannula 50 inserted through the incision,posterior the ramus IR, and through the support 300 until the leadingend of the cannula 50 slides under the periosteum tissue PT. The leadingend of the cannula 50 is sharp and so configured to pierce theperiosteum tissue PT and deliver the anchor 42 a between the bone andunder the periosteum tissue PT.

FIG. 65 is a schematic view of the first cannula 50 withdrawn from theincision leaving the first anchor 42 a embedded in or secured to theperiosteum tissue PT. The suture 300 trails away from the first anchor42 a out of the patient through the incision.

FIG. 66 is a schematic view of the second cannula 50 inserted into theincision, posterior to the ramus IR, and through the support 310. Thesurgeon directs the introducer in a distal direction until the sharpdistal end of the cannula 50 pierces the periosteum tissue PT anddelivers the anchor 42 b. The suture 300 remains connected between thefirst anchor 42 a and the second anchor 42 b, and the stopper 302 isoutside of the patient's body.

FIG. 67 is a schematic view of the support 310 secured on a first sideby the first anchor 42 a and secured on an opposite second side by thesecond anchor 42 b. The suture 300 is looped through the first anchor 42a and includes a first segment 304 between the anchor 42 a and thestopper 302, a second segment 306 between the stopper 302 and the anchor42 b, and the trailing portion 300. Pulling on the trailing portion 300operates to cinch the stopper 302 into a supporting configurationagainst the support 310.

FIG. 68A is a schematic view of the support 310 secured relative to thepelvis, and FIG. 68B is a bottom view of the support 310 as securedbetween the opposed descending rami IR. The trailing portion 300 of thesuture has been pulled by the surgeon in a proximal direction resultingin the stopper 302 being guided up to the support 310. The stopper 302is configured to engage with the suture 300 and maintain the support 310in position relative to the urethra U.

FIG. 68B illustrates the first segment 304 of the suture with the slackremoved and tightened against the support 310, and the second segment306 of the suture with the slack removed and tightened against thesupport 310. The stopper 302 secures the segments 304, 306 against thesupport 310.

Embodiments described above include pushing the pointed leading end ofthe cannula 50 through both the support 310 and the periosteum tissue PTto secure the anchor 42 in the patient. The trailing suture 300 isaccessible by the surgeon outside of the patient's body to allow thesurgeon to direct the stopper 302 upwards (or inwards) to the support310.

In an alternative embodiment of this approach, the surgeon pushes theleading end of the cannula 50 into the periosteum tissue PT of the firstramus IR and engages the first anchor 42 a in the periosteum tissue,while leaving a single strand of suture 300 trailing from the firstanchor 42 a and out of the vaginal incision. The surgeon completes asimilar process on the contralateral side by pushing the leading end ofthe cannula 50 into periosteum tissue PT of the second ramus IR andengaging a second, different anchor 42 b with the periosteum tissue PT.A second, separate suture strand is left trailing from the second anchorand out of the vaginal incision. Along these two trailing suture strandsthe surgeon delivers a first end portion of a sling 310 along the firstsuture strand, through the vaginal incision and to the first ramus IR ofthe pelvis, and a second end portion of the sling 310 along the secondsuture and through the vaginal incision to the second ramus IR of thepelvis. The surgeon subsequently secures each suture strand, for exampleby tying the strand to form a knot at the sling 310.

Embodiments described above include pushing the pointed leading end ofthe cannula 50 through both the support 310 and the periosteum tissue.The trailing suture 300 is accessible by the surgeon outside of thepatient to allow the surgeon to direct the stopper 302 upwards (orinwards) to the support 310. In an alternative embodiment of thisapproach, the surgeon fixates a support material 310 between opposedmembranes M of the opposed obturator foramen OF. In such a procedure,the surgeon guides the leading end of the cannula 50 through a first endportion of the sling 310, through the vaginal incision, and into themembrane M of the first obturator foramen OF to engage the first anchorwith the membrane M, thus leaving a suture connected to the firstanchor. The surgeon performs a similar procedure on the contralateralside by loading another anchor into the cannula 50 and guiding theleading end of the cannula 50 through a second end portion of the sling310, through the vaginal incision, and into a membrane M of a secondobturator foramen OF. The surgeon engages the second anchor with themembrane M, where the suture is coupled to the second anchor. Thesurgeon pulls on a free end of the suture and secures the first endportion of the sling 310 to the first membrane M of the first obturatorforamen OF and secures the second end portion of the sling 310 to themembrane M of the second obturator foramen OF.

FIGS. 69-73 are schematic views of embodiments of a method of anchoringa support to tissue.

FIG. 69 is a schematic view of a trans-obturator TO path that isfollowed by the cannula 50 to place the anchor 42 into the membrane M ofthe obturator foramen OF. The trans-obturator TO path extends from theincision posterior to the ramus (i.e., behind the ramus) and into themembrane M. It is desirable to place the anchor 42 in a lower quadrantof the membrane M. In one approach, the surgeon palpates along theinferior portion of the ramus IR and guides the cannula 50 along andbehind the ramus IR into the membrane M.

FIG. 70 is a schematic view of the cannula 50 introduced along thetrans-obturator TO path posterior to the ramus IR and into the membraneM. The surgeon provides a pushing distal force that drives the anchor 42into, but not through, the membrane M. The anchor is placed in themuscle of the OF membrane and not driven all the way through themembrane M from the posterior side to the anterior side. However, in oneembodiment the anchor 42 is inserted entirely through the obturatorforamen OF from the posterior side to the anterior side of the membraneM.

FIG. 71 is a schematic view of the anchor 42 inserted into the membraneM with the suture 24 extending posterior to the ramus IR and out of theincision. In this configuration, the suture 24 is available to deliversupport material or other materials along the trans-obturator TO pathposterior to the ramus IR upwards to the membrane M that covers theobturator foramen OF.

FIG. 72 is a schematic view after the surgeon completes the processdescribed in FIGS. 69-71 on the contralateral side. The cannula 50 ofthe introducer has been directed along the trans-obturator TO pathposterior to the ramus IR until the anchor 42 b is positioned andinserted into the membrane M covering the obturator foramen OF. Thesuture 24 b trails away from the anchor 42 b and exits the incision.With this configuration, the first suture 24 a is connected to the firstanchor 42 a that secured in a first one of the membranes M of theobturator foramen OF, and the second suture 24 b is connected to thesecond anchor 42 b that is secured in the membrane M of the opposedsecond obturator foramen OF. The sutures 24 a, 24 b extend out of theincision and are available to deliver the support material through theincision to support the urethra or other body organ.

FIG. 73 is a schematic view of a support 400 inserted into a patient. Afirst end of the support 400 has been engaged with and delivered alongthe entire length of the first suture 24 a to the anchor 42 a. A secondend of the support 400 has been engaged with and delivered along theentire length of the second suture 24 b up to the second anchor 42 b.The support 400 thus extends like a hammock from the first anchor 42 ain the first membrane M of the first obturator foramen OF across themidline of the patient to the second anchor 42 b in the second membraneM of the second obturator foramen OF. The surgeon terminates the firstsuture 24 a at the support 400, for example by tying a knot, andlikewise terminates the second suture 24 b at the support 400. Theexcess length of suture 24 a, 24 b is removed and the incision isclosed.

FIG. 74 is a schematic view illustrating embodiments of methods ofanchoring the support 700 to the pelvis of a male patient. The pre-pubicside 708 of the support 700 is anchored at a superior location of thepelvis to the periosteum tissue anterior the pubic bone PB. The arms704, 706 of the support 700 are suitably anchored to the periosteumtissue PT of the inferior ischial pubic ramus IR (anterior or posterior)or to the membrane M of the pelvis.

The method includes elevating and compressing the bulbar urethra of themale patient and includes:

forming a perineal incision in the male patient;

inserting a first arm 704 located on a first side of the support 700into the perineal incision, directing an end portion of the first arm704 toward an obturator foramen OF of the pelvis, and fixing the endportion of the first arm 704 to either Location A) the membrane M of theobturator foramen OF or Location B) the periosteum tissue of the ramusIR adjacent to the obturator foramen OF; and

inserting a second arm 706 located on a second side of the support 700into the perineal incision, directing an end of the second arm 706toward a second obturator foramen OF of the pelvis, and fixing the endportion of the second arm 706 to one of C) the membrane M of the secondobturator foramen OF or D) the periosteum tissue of the ramus IRadjacent to the second obturator foramen OF; and

inserting a pre-pubic side 708 of the support 700 into the perinealincision and directing the pre-pubic side 708 of the support 700anterior to the pelvis towards a pubic bone PB of the pelvis; and

pushing the anchor 42 through the pre-pubic side 708 of the support 700and into periosteum tissue PT over the pubic bone PB and engaging theanchor 42 in the periosteum tissue PT of the pubic bone PB; and

securing the pre-pubic side 708 of the support 700 against theperiosteum tissue PT of the pubic bone PB.

The arms 704, 706 of the support 700 are suitably anchored to theperiosteum tissue PT posterior to (i.e., behind) the ischial ramus IR oranterior to the ischial ramus IR. Mindful of this, and as examples, FIG.74 illustrates the arm 704 anchored to the membrane M at a posteriorlocation relative to the ischial ramus IR (Location A) and the arm 706anchored to the anterior surface of the ischial ramus IR (Location B).It is suitable to attach either arm 704, 106 to the inferior edge of theischial pubic ramus IR.

An addition to the method of anchoring the support 700 relative to thepelvis includes: inserting a body portion of the anchor 42 into a lumenin a cannula 50; inserting a leading end of the cannula 50 and theanchor 42 into the perineal incision; and pushing the leading end of thecannula 50 and the anchor 42 into the periosteum tissue PT of the pubicbone PB.

An addition to the method of anchoring the support 700 relative to thepelvis includes: leaving a suture 24 attached to the anchor 42 trailingfrom the anchor 42 and out of the perineal incision; and tying thesuture 24 against the pre-pubic 708 side of the support 700 and fixingthe pre-pubic side 708 of the support 700 against the periosteum tissuePT of the pubic bone PB.

An addition to the method of anchoring the support 700 relative to thepelvis includes: leaving the suture 24 attached to the anchor 42trailing from the anchor 42 and out of the perineal incision; andsliding a stopper 150 attached to the suture 24 from the perinealincision inward toward the pubic bone PB and fixing the pre-pubic side708 of the support 700 against the periosteum tissue PT and between thestopper 150 and the pubic bone PB.

An addition to the method of anchoring the support 700 relative to thepelvis includes: inserting a body portion of the anchor 42 into a lumenin a cannula 50; inserting a leading end of the cannula 50 and theanchor 42 into the perineal incision; pushing the leading end of thecannula 50 and the anchor 42 into the membrane M of the first obturatorforamen OF; and fixing the end portion of the first arm 704 to themembrane M of the first obturator foramen OF.

An addition to the method of anchoring the support 700 relative to thepelvis includes: inserting the anchor 42 into a lumen in a cannula 50;inserting a leading end of the cannula 50 and the anchor 42 into theperineal incision; pushing the leading end of the cannula 50 and theanchor 42 into the periosteum tissue PT of the ramus IR adjacent to thefirst obturator foramen OF; and fixing the end portion of the first arm704 to the periosteum tissue PT of the ramus IR adjacent to the firstobturator foramen OF.

One embodiment provides a tissue anchor comprising:

a body oriented on a longitudinal axis, the body having a leading tip, aleading end portion extending from the leading tip, a trailing endportion connected to the leading end portion, with the trailing endportion terminating in a trailing tip that is located opposite of theleading tip;

-   -   first and second protrusions formed on the leading end portion        of the body, with each of the first and second protrusions        extending outward in a radial direction perpendicular to the        longitudinal axis, with a first anchor width measured between        the first and second protrusions being greater than a second        anchor width measured at the trailing end portion of the body;

a tissue engaging fin integrated with the leading end portion of thebody and oriented in a direction perpendicular to the radial directionof the first and second protrusions, the tissue engaging fin having afin width and provided with an eyelet formed through the fin width; and

a gripping tab removably attached to the tissue engaging fin.

One embodiment provides a method of fixating an implantable material ina patient, the method comprising:

forming an incision in the patient;

inserting an anchor into a bore of a cannula, with the anchor attachedto a support by a suture having ends that are bonded together to form acontinuous suture loop that is looped through an eyelet of the anchorand engaged through the support;

inserting the cannula into the incision and along a cannula path intosoft tissue;

ejecting the anchor out of the bore of the cannula and into the softtissue;

pulling on the suture in a direction away from the patient, and rotatingthe anchor to position a length of the anchor transverse to the cannulapath; and

breaking the continuous suture loop, tying a knot in the suture, andfixating the support in the patient.

One embodiment provides a tissue anchor system comprising:

a support material;

a suture engaged with the support material;

an anchor comprising a body, a fin extending from the body in a firstdirection with an eyelet formed in the fin, a pair of radial barrelsextending from the body in a radial direction perpendicular to the firstdirection, and a gripping tab removably attached to the fin, with thesuture engaged with the eyelet of the fin; and

an introducer having a cannula defining a bore sized to receive the bodyof the anchor and a slot formed in a wall of the cannula, with the slotsized to receive the fin of the anchor, and an ejection mechanismprovided to eject the anchor out of the cannula.

One embodiment provides a method of treating urinary incontinence in apatient, the method comprising:

forming one and only one incision in the patient and exposing tissue ofa urethra;

implanting a base of a support in the patient by placing an anchor intotissue of an obturator foramen, with the anchor attached to the base ofthe support by a suture having ends that are bonded together to form acontinuous suture loop that is looped through an eyelet of the anchorand engaged through the base of the support;

breaking the continuous suture loop, tying a knot in the suture, andfixating the base of the support in the patient;

implanting an arm of the support in the patient by placing a secondanchor into periosteum tissue lateral to a pubic symphysis, with thesecond anchor attached to the arm of the support by a second suturehaving ends that are bonded together to form a second continuous sutureloop that is looped through an eyelet of the second anchor and engagedthrough the arm of the support; and

breaking the second continuous suture loop, tying a knot in the secondsuture, and fixating the arm of the support over the periosteum tissue.

FIG. 75 is a perspective view of one embodiment of an adjustableincontinence treatment device 800. The incontinence treatment device 800(device 800) includes a support 802 connected at one end 804 to a fixedanchor 42FX by a first suspending member 806 and a second suspendingmember 808 attached at an opposite second end 810 of the support 802that is movable through the eyelet 48 of an adjustable anchor 42AJ. Eachanchor 42FX and 42AJ includes the removable insertion tab 40 describedabove that aids in placing the anchor into a cannula of an introducertool.

The device 800 is implanted in a patient to treat urinary incontinence.In one method of placing the device 800, the patient is placed in alithotomy position and prepped for surgery. A single (one and only one)incision is made in an upper wall of the vagina (the anterior wall) andtissue is dissected to expose a portion of the urethra. The left handtool 28 b (FIG. 1) is employed to place the fixed anchor 42FX in theobturator foramen (OF) on the left side of the patient. The anchor 42FXis inserted into the tool 28 b through the use of the insertion tab 40.The insertion tab 40 is removed and discarded. The introducer 28 b isinserted into the vaginal incision and passed along a path behind thedescending ischial pubic ramus until the tip of the introducer 28 bpasses through the muscle of the left side OF. An audible “pop” can beheard in some instances, indicating that the tip of the introducer haspassed through the muscle of the foramen. The button 56 is advanced andthe fixed anchor 42FX is inserted into the left OF. The support 802 isthus fixed relative to the left side OF.

The right hand tool 28 a (FIG. 1) is employed to place the adjustableanchor 42AJ in the OF on the right side of the patient. The anchor 42AJis inserted into the tool 28 a through the use of the insertion tab 40.The insertion tab 40 is removed and discarded. The introducer 28 a isinserted into the vaginal incision and passed along a path behind thedescending ischial pubic ramus on the right side of the patient untilthe tip of the introducer 28 a passes through the muscle of the rightside OF. An audible “pop” can be heard in some instances, indicatingthat the tip of the introducer has passed through the muscle of theforamen. The button 56 is advanced and the adjustable anchor 42AJ isinserted into the right OF. The support 802 is thus suspended under theurethra and the two anchors 42FX and 42AJ. The second suspending member808 is movable through the eyelet 48 of the adjustable anchor 42AJ andextends out of the incision. The surgeon positions the support 802relative to the urethra to achieve a desired location by sliding thesuspending member 808 through the adjustable anchor 42AJ. When thesupport is positioned as desired by the surgeon, the surgeon then tiesor terminates the second suspending member 808 to itself, to the support802, or to tissue. This allows the surgeon to adjust the location of thesupport 802 to accommodate different body types and variations in theprocedure. The excess portions of the suspending members 806, 808 areremoved and the incision is closed.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention islimited only by its claims and their equivalents.

What is claimed is:
 1. A method of treating urinary incontinence in a patient, the method comprising: forming one and only one incision in the patient and exposing tissue of a urethra; implanting a base of a support in the patient by placing a first anchor into tissue of an obturator foramen, with the first anchor attached to the base of the support by a suture having ends that are bonded together to form a first continuous suture loop that is looped through an eyelet of the first anchor and engaged through the base of the support; breaking the first continuous suture loop, tying a knot in the suture, and fixating the base of the support in the patient; implanting an arm of the support in the patient by placing a second anchor into periosteum tissue lateral to a pubic symphysis, with the second anchor attached to the arm of the support by a second suture having ends that are bonded together to form a second continuous suture loop that is looped through an eyelet of the second anchor and engaged through the arm of the support; and breaking the second continuous suture loop, tying a knot in the second suture, and fixating the arm of the support over the periosteum tissue.
 2. The method of claim 1, further comprising: fixating the base of the support in the patient, pulling on the arm of the support and applying tension to the support, and fixating the arm of the support over the periosteum tissue.
 3. The method of claim 1, comprising inserting an entirety of the support through the one and only one incision in the patient.
 4. The method of claim 1, further comprising: placing a separate anchor into tissue of a second obturator foramen, with the separate anchor attached to the base of the support by a separate suture having ends that are bonded together to form a separate continuous suture loop that is looped through an eyelet of the separate anchor and engaged through the base of the support; and breaking the separate continuous suture loop, tying a knot in the separate suture, and fixating the base of the support in the patient by suspending the base of the support to the second obturator foramen with the separate suture.
 5. The method of claim 1, comprising inserting the second anchor into a bore of a cannula; inserting the cannula into the one and only one incision and along a cannula path into the periosteum tissue; ejecting the second anchor out of the bore of the cannula and into the periosteum tissue; and pulling on the second suture in a direction away from the patient, and rotating the second anchor to position a length of the second anchor transverse to the cannula path.
 6. The method of claim 1, comprising ejecting the first anchor out of a bore of a cannula, moving the first anchor up a ramp formed by the cannula, rotating the first anchor away from the cannula, and placing the first anchor into the tissue of the obturator foramen.
 7. The method of claim 1, comprising ejecting the second anchor out of a bore of a cannula, moving the second anchor up a ramp formed by the cannula, rotating the second anchor away from the cannula, and placing the second anchor into the periosteum tissue lateral to the pubic symphysis.
 8. The method of claim 1, wherein the first anchor includes an eyelet formed in a fin that is integrated to a leading end portion of the first anchor, the method comprising: placing the first anchor along a pathway into the tissue of the obturator foramen; and rotating the first anchor to position a length of the first anchor transverse to the pathway and pulling the fin into engagement with the tissue of the obturator foramen.
 9. The method of claim 1, wherein the second anchor includes an eyelet formed in a fin that is integrated to a leading end portion of the second anchor, the method comprising: placing the second anchor along a pathway into the periosteum tissue; and rotating the second anchor to position a length of the second anchor transverse to the pathway and pulling the fin into engagement with the periosteum tissue. 